CEREGLIDE

Additional Manufacturer Narrative

MANUFACTURER¿S REF. NO: (B)(4). INFORMATION REGARDING PATIENT IDENTIFIER, DATE OF BIRTH, AGE, SEX, GENDER, WEIGHT, RACE, AND ETHNICITY WERE NOT PROVIDED. SECTION B.3: DATE OF EVENT: THE DATE OF THE EVENT WAS NOT REPORTED / KNOWN. SECTION D.2B: PROCODE IS NRY/QJP. SECTION D.4: THE EXPIRATION DATE OF THE DEVICE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. THE FULL UDI IS NOT AVAILABLE WITHOUT THE EXPIRATION DATE. SECTION E.1: THE INITIAL REPORTER PHONE IS NOT AVAILABLE / REPORTED. SECTION H.4: THE DEVICE MANUFACTURE DATE IS NOT KNOWN AS THE DEVICE LOT NUMBER IS NOT AVAILABLE / NOT REPORTED. BASED ON COMPLAINT INFORMATION, THE DEVICE IS NOT AVAILABLE TO BE RETURNED FOR ANALYSIS. THE DEVICE LOT NUMBER WAS NOT AVAILABLE. THE MANUFACTURING DOCUMENTATION REVIEW COULD NOT BE PERFORMED WITHOUT THE LOT NUMBER. PRODUCT ANALYSIS CANNOT BE CONDUCTED AS THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO DETERMINATION OF CAUSES AND POSSIBLE CONTRIBUTING FACTORS COULD BE MADE. AS SUCH, THE INVESTIGATION WILL BE CLOSED. THROMBOEMBOLISM IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH MECHANICAL THROMBECTOMY PROCEDURES AND IS ALSO MENTIONED IN THE INSTRUCTIONS FOR USE (IFU) FOR THE CEREGLIDE71 INTERMEDIATE CATHETER. THERE WAS NO ALLEGED QUALITY ISSUE RELATED TO THE USED DEVICE, AS THE DEVICE PERFORMED AS INTENDED. THERE ARE VESSEL CHARACTERISTICS, DEVICE INTERACTION, AND OPERATOR TECHNIQUES THAT MAY HAVE CONTRIBUTED TO THE EVENT. THE REPORTED THROMBOEMBOLIC EVENT APPEARS MORE TEMPORALLY AND MECHANISTICALLY ASSOCIATED WITH THROMBECTOMY MANEUVERS INVOLVING CLOT ENGAGEMENT AND RETRIEVAL, SUCH AS THE USE OF THE STENT RETRIEVER AND/OR ASPIRATION SYSTEM, RATHER THAN THE SUPPORT CATHETER ITSELF. NO INFORMATION WAS PROVIDED TO SUGGEST THAT THE CEREGLIDE71 CATHETER DIRECTLY CONTRIBUTED TO THE EVENT. HOWEVER, THROMBOEMBOLISM WITHIN THE BASILAR CIRCULATION REPRESENTS A SERIOUS EVENT WITH THE POTENTIAL FOR SIGNIFICANT PATIENT HARM. THEREFORE, ALTHOUGH DIRECT CAUSALITY TO THE CEREGLIDE71 CATHETER CANNOT BE ESTABLISHED, THIS EVENT MEETS 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. WITH THE INFORMATION AVAILABLE AND WITHOUT THE COMPLAINT PRODUCT AVAILABLE TO BE RETURNED FOR ANALYSIS, THE REPORTED PRODUCT ISSUE DOCUMENTED IN THE COMPLAINT CANNOT BE CONFIRMED THROUGH FUNCTIONAL EVALUATION AND ANALYSIS. THE LOT NUMBER OF THE DEVICE IS NOT KNOWN; THEREFORE, MANUFACTURING DOCUMENTATION REVIEW WAS NOT PERFORMED. ASSIGNMENT OF ROOT CAUSE FOR THE EVENT REMAINS SPECULATIVE AND INCONCLUSIVE, BASED ON THE LIMITED INFORMATION PROVIDED AND WITHOUT THE RETURN OF THE COMPLAINT SAMPLE; HOWEVER, IT IS POSSIBLE THAT CLINICAL AND PROCEDURAL FACTORS, INCLUDING DEVICE MANIPULATION / INTERACTION MAY HAVE CONTRIBUTED TO THE REPORTED FAILURE. AS PART OF THE POST MARKET SURVEILLANCE PROGRAM, INFORMATION FROM THIS COMPLAINT IS TRENDED FOR STATISTICAL SIGNALS AND CORRECTIVE / PREVENTIVE ACTION MAY BE TRIGGERED LATER. 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. MISSING INFORMATION FROM THIS REPORT IS IDENTIFIED AS BLANK; THIS INFORMATION WAS NOT PROVIDED IN THE REPORTED EVENT OR AVAILABLE AT THE TIME OF REPORT SUBMISSION. THE MANUFACTURER WILL SUBMIT A SUPPLEMENTAL REPORT IF NEW FACTS ARISE WHICH MATERIALLY ALTER INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

Description of Event or Problem

THE HEALTHCARE PROFESSIONAL REPORTED THAT DURING A MECHANICAL THROMBECTOMY PROCEDURE TARGETING AN OCCLUSION IN THE BASILAR ARTERY TO TREAT AN ACUTE-STAGE CEREBRAL INFARCTION, ALL DEVICES WERE USED IN ACCORDANCE WITH THEIR RESPECTIVE INSTRUCTIONS FOR USE (IFUS). THE THROMBECTOMY WAS PERFORMED USING A 125CM CEREGLIDE 71 INTERMEDIATE CATHETER (NIC71125C / LOT# UNKNOWN), VECTA 46 INTERMEDIATE CATHETER (STRYKER), AND A 3MM TREVO® RETRIEVER (STRYKER). A PORTION OF THE THROMBUS WAS SUCCESSFULLY RETRIEVED; HOWEVER, ¿A NEW EMBOLIZATION OCCURRED IN THE POSTERIOR CEREBRAL ARTERY. THE THROMBUS IN THE POSTERIOR CEREBRAL ARTERY WAS SUBSEQUENTLY RETRIEVED USING A NIMBUS CLOT EXTRACTOR AND THE VECTA 46. A TICI SCORE OF 3 RECANALIZATION WAS ACHIEVED.¿ CONTINUOUS FLUSH WAS MAINTAINED DURING THE PROCEDURE. A PHENOM¿ MICROCATHETER (MEDTRONIC) WAS ALSO USED.