CEREGLIDE 92

Additional Manufacturer Narrative

MANUFACTURER REF# (B)(4) INFORMATION REGARDING PATIENT WEIGHT, HEIGHT, RACE, AND ETHNICITY WAS NOT REPORTED. AN ANALYSIS OF THE PRODUCT COULD NOT BE PERFORMED SINCE A PHYSICAL SAMPLE WAS NOT RECEIVED FOR EVALUATION. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE 31754503 NUMBER, AND NO INTERNAL ACTIONS RELATED TO THE MALFUNCTION WERE IDENTIFIED. SUBARACHNOID HEMORRHAGE IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH THE CEREGLIDE92 INTERMEDIATE CATHETER AND IS MENTIONED IN THE INSTRUCTIONS FOR USE (IFU). THERE ARE CLINICAL AND PROCEDURAL FACTORS, INCLUDING VESSEL CHARACTERISTICS, DEVICE INTERACTION, AND OPERATOR TECHNIQUE THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. THE AVAILABLE INFORMATION DOES NOT SUPPORT IDENTIFICATION OF A SINGLE DEFINITIVE CAUSE FOR THE HEMORRHAGE; MULTIPLE POTENTIAL ETIOLOGIES WERE REPORTED, INCLUDING INJURY TEMPORALLY ASSOCIATED WITH THE EMBOTRAP DEVICE, DIFFICULTY WITHDRAWING THE CEREGLIDE92 CATHETER FROM THE DISTAL M1 SEGMENT WHICH MAY HAVE RESULTED IN VESSEL SHEARING, AND POSSIBLE VESSEL PERFORATION BY THE MICROWIRE. THE PHYSICIAN REPORTED THAT THE CEREGLIDE92 CATHETER WAS POSITIONED DISTALLY WITHIN THE M1 SEGMENT, WHICH MEASURED APPROXIMATELY 2MM IN DIAMETER, AND NOTED DIFFICULTY WITHDRAWING THE CATHETER FROM THIS LOCATION. GIVEN THE REPORTED VESSEL DIAMETER OF 2MM, THE VESSEL SIZE APPEARS RELATIVELY SMALL FOR DISTAL POSITIONING OF THE CEREGLIDE92 CATHETER (WHICH HAS AN INNER DIAMETER OF ABOUT 2.34 MM AND A DISTAL END OUTER DIAMETER OF ABOUT 2.59 MM). IT IS IMPORTANT TO NOTE THAT THE IFU FOR THE CEREGLIDE92 INTERMEDIATE CATHETER STATES THAT PRIOR TO USE, USERS ARE TO ENSURE THAT THE DIMENSIONS (E.G., DIAMETER AND LENGTH) OF THE CEREGLIDE 92 CATHETER SYSTEM ARE APPROPRIATE FOR THE TARGET VASCULATURE. WITHDRAWAL DIFFICULTY COULD REQUIRE THE USE OF SIGNIFICANT FORCE, WHICH COULD RESULT IN DEVICE SEPARATION, DISSECTION, PERFORATION, OR OTHER VESSEL DAMAGE. SINCE THE PHYSICIAN CONSIDERED THAT VESSEL INJURY MAY HAVE OCCURRED SECONDARY TO SHEARING FORCES DURING CATHETER WITHDRAWAL, A CAUSAL RELATIONSHIP BETWEEN THE HEMORRHAGE AND THE CEREGLIDE92 CATHETER CANNOT BE EXCLUDED. THEREFORE, THIS EVENT DOES MEET US FDA REPORTING CRITERIA UNDER 21 CFR 803 WITH A CLASSIFICATION OF ¿SERIOUS INJURY.¿ THE FILE WILL BE RE-REVIEWED IF ADDITIONAL INFORMATION IS RECEIVED AT A LATER DATE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED TO IDENTIFY STATISTICAL SIGNALS FOR CONSIDERATION OF FURTHER CORRECTION ACTION. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY CERENOVUS, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, CERENOVUS, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

IT WAS REPORTED, VIA A HEALTHCARE PROFESSIONAL, THAT AN EMBOTRAP III 5 MM X 37 MM (ET307537/ 25K008AV) AND A CEREGLIDE92 INTERMEDIATE CATHETER SBC 92 122 CM CE (SBC92122CA/ 31754503), WERE USED FOR A MECHANICAL THROMBECTOMY PROCEDURE TO TREAT A VERY LARGE CLOT BURDEN FROM THE LEFT INTERNAL CAROTID ARTERY (ICA) TO THE M2 SEGMENT OF THE MIDDLE CEREBRAL ARTERY (MCA). DURING THE PROCEDURE, THE USER REPORTED THAT AFTER THE SECOND PASS USING THE EMBOTRAP III DEVICE, A SUBARACHNOID HEMORRHAGE AT THE LOCATION OF THE OCCLUSION WAS OBSERVED. THE HEMORRHAGE WAS TREATED WITH COIL EMBOLIZATION. THE SURGERY WAS DELAYED BY 15 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE EVENT WAS INITIALLY REPORTED AS SUCH, ¿DR USED A CEREGLIDE 92 TO CLEAR A VERY LARGE CLOT BURDEN FROM LEFT ICA TO M2. HE THEN TRIED USING A EMBOTRAP 537 TO CLEAR AN OCCLUSION AT THE LEFT M1/M2. FIRST PASS DID NOT RESULT IN CLOT RETRIEVAL AND AFTER 2ND PASS DR NOTICE A SUBARACHNOID HEMORRHAGE AT THE LOCATION OF THE OCCLUSION, WHICH THEY THEN NEEDED TO COIL. THE SURGERY WAS DELAYED BY 15 MINUTES DUE TO THE REPORTED EVENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED.¿ ON 18-JUN-2026, ADDITIONAL INFORMATION ON THE CASE WAS RECEIVED. PER THE INFORMATION PROVIDED, THE CLOT AT THE ICA ORIGIN WAS TOO HARD FOR THE TRAXCESS 14 WIRE (MICROVENTION), REQUIRING REMOVAL OF THE INNERGLIDE/CEREGLIDE92 AND USE OF A TERUMO WIRE FOLLOWED BY ANGIOPLASTY WITH A VIATRAC 14 PLUS (ABBOTT VASCULAR) TO GAIN ACCESS. THE CEREGLIDE92 WAS THEN USED TO REMOVE CLOT BURDEN IN THE ICA AND M1, BUT THE M2 REMAINED BLOCKED, SO THE EMBOTRAP WAS USED. ON LATER REVIEW OF THE SCANS, THE PHYSICIAN NOTICED CONTRAST STAINING AFTER THE FIRST EMBOTRAP PASS, SUGGESTING BLEEDING THAT WAS NOT RECOGNIZED AT THE TIME. THE PHYSICIAN ALSO NOTED THAT THE CEREGLIDE92 CATHETER WAS QUITE DISTAL IN THE M1 (WHICH MEASURED ABOUT 2 MM IN DIAMETER) AND 'WEDGED'; HE STRUGGLED TO REMOVE THE CEREGLIDE92 FROM THE DISTAL POSITION IN THE M1. IN RETROSPECT, HE THINKS IT MAY HAVE CAUSED SOME SHEARING OF THE M2 VESSEL, AND/OR THERE MAY HAVE BEEN PERFORATION OF THE M2 VESSEL WITH THE MICROWIRE. ONCE HE SAW THE BLEED AFTER THE SECOND PASS, HE THEN COILED THE M2 VESSEL TO OCCLUDE THE BLEEDING. THE EVENT WAS REPORTED AS SUCH, ¿CLOT WAS TOO HARD AT ICA ORIGIN TO GET TRAXCESS 14 WIRE THROUGH TO ALLOW INNERGLIDE/CG 92 TO GET TO THE CLOT FACE, SO REMOVED INNERGLIDE/CG 92 (WHICH WHEN HE DID A COUPLE OF LARGE CLOTS CAME OUT OF THE LGS) AND THEN TOOK A TERUMO WIRE THROUGH THE CLOT AND THEN ANGIOPLASTY WITH VIATRAC 14 PLUS OF PROXIMAL ICA TO ALLOW ACCESS FOR INNERGLIDE/CG 92. USED CG 92 TO 'HOOVER' CLOT BURDEN IN ICA AND INTO M1. HOWEVER, M2 STILL BLOCKED, SO TOOK AN ET 537. IN LOOKING AT THE SCANS TODAY, DR NOTICED AFTER THE FIRST PASS WITH ET SOME 'CONTRAST STAINING' WHICH HE DID NOT SEE WEDNESDAY NIGHT. MO SAID CG 92 WAS QUITE DISTAL IN THE M1 (WE MEASURED M1 DIAMETER TODAY AND ABOUT 2 MM) AND 'WEDGED'...AND AS HE STRUGGLED TO REMOVE THE CG 92 FROM THE DISTAL POSITION IN THE M1 HE THINKS IN RETROSPECT IT MAY HAVE CAUSED SOME SHEARING OF THE M2 VESSEL AND/OR THERE MAY HAVE BEEN PERFORATION OF THE M2 VESSEL WITH THE MICROWIRE. DR SAID HAD HE NOTICED THE CONTRAST STAINING (WHICH INDICATES A BLEED) AFTER THE 1ST ET PASS, HE WOULD NOT HAVE TRIED A 2ND ET PASS. WHEN THEY SAW THE BLEED AFTER THE 2ND PASS THEY THEN COILED THE M2 VESSEL TO OCCLUDE.¿