SHORTCUT

Additional Manufacturer Narrative

THE PROCEDURE INCLUDED A DUAL LEAFLET SPLIT USING THE SC DEVICE, FOLLOWED BY AN IMPLANTATION OF A 26MM SAPIEN 3 ULTRA RESILIA WITH A POST-IMPLANT SAVR FRAME FRACTURE. SOLOPACE GW AND SENTINEL EMBOLIC PROTECTION DEVICE WERE USED DURING THE PROCEDURE. THE PROCEDURE WAS PERFORMED UNDER CONTINUOUS FLUORO/ECHO AND TEE GUIDANCE, WITH MULTIPLE INTRA-PROCEDURAL VERIFICATION STEPS CONFIRMING APPROPRIATE DEVICE POSITIONING AND ABSENCE OF ACUTE COMPLICATIONS. THE RIGHT LEAFLET SPLITTING INITIALLY SHOWED LIMITED PROGRESS, BUT AFTER REPOSITIONING AND CONFIRMATION VIA FLUORO/ECHO, THE SPLIT WAS SUCCESSFULLY COMPLETED. TEE ASSESSMENTS PERFORMED BEFORE AND AFTER ACTIVATION CONFIRMED NO PERICARDIAL EFFUSION AND STABLE HEMODYNAMICS. THE LEFT LEAFLET SPLIT WAS SUBSEQUENTLY PERFORMED UNDER OPTIMIZED POSITIONING AND IMAGING GUIDANCE, WITH SUCCESSFUL COMPLETION AND NO EVIDENCE OF EFFUSION OR STRUCTURAL DAMAGE ON TEE. FOLLOWING REMOVAL OF THE SC DEVICE, THE SAPIEN TAVR SYSTEM WAS ADVANCED OVER THE SAME GW AND SUCCESSFULLY DEPLOYED. A POST-DILATION SAVR FRAME FRACTURE WAS THEN PERFORMED USING A 26 MM BALLOON. FINAL INTRA-PROCEDURAL IMAGING DEMONSTRATED PRESERVED CORONARY FLOW, NO PERICARDIAL EFFUSION, NO VISIBLE AORTIC ARCH ABNORMALITIES, AND NO EVIDENCE OF CONTRAST EXTRAVASATION. THE PATIENT REMAINED HEMODYNAMICALLY STABLE THROUGHOUT THE PROCEDURE AND AT ITS CONCLUSION. APPROXIMATELY 28 HOURS POST-PROCEDURE, PATIENT DEVELOPED CHEST DISCOMFORT. CT IMAGING REVEALED A LOCALIZED INTIMAL FLAP DEFECT NEAR THE RIGHT INNOMINATE ARTERY AND A THINNED LV WALL/APEX DEFECT. THE PATIENT UNDERWENT EMERGENCY OPEN-HEART SURGERY THE SAME DAY FOR A 28MM HEMASHIELD GRAFT IN THE ASCENDING AORTA SEGMENT AND A PLEDGETED SUTURE REPAIR AT THE LV APEX. BASED ON THE AVAILABLE INFORMATION, THE EVENT INVOLVED SERIOUS PATIENT INJURY FOLLOWING A PROCEDURE IN WHICH THE SHORTCUT DEVICE WAS USED. PI-CARDIA MEDICAL DIRECTOR REVIEWED THE CASE AND NOTED THAT IT CANNOT BE DETERMINED WHETHER THE AORTIC INTIMAL TEAR WAS FROM THE SENTINEL EMBOLIC PROTECTION DEVICE, TAVR PROCEDURE, SOLOPACE GW, SC OR BALLOON FRACTURING. IT WAS FURTHER NOTED THAT THE PROXIMITY OF THE INTIMAL FLAP TO THE ORIGIN OF THE INNOMINATE ARTERY MAY SUGGEST A POTENTIAL ASSOCIATION WITH THE SENTINEL DEVICE, ALTHOUGH SUCH COMPLICATIONS ARE CONSIDERED RARE. ADDITIONALLY, THE TIMING AND MECHANISM OF THE SERIOUS INJURY REMAIN UNCLEAR, AND IT CANNOT BE RELIABLY EXCLUDED THAT IT MAY BE RELATED TO THE SHORTCUT PROCEDURE OR ASSOCIATED INSTRUMENTATION. CONSEQUENTLY, A CAUSAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT CANNOT BE RULED OUT. ACCORDINGLY, THE EVENT IS CONSIDERED REPORTABLE, AS THE DEVICE MAY HAVE CONTRIBUTED TO A SERIOUS ADVERSE EVENT RESULTING IN SIGNIFICANT PATIENT INJURY, DESPITE THE DEVICE PERFORMING AS INTENDED AND THE PRESENCE OF OTHER PROCEDURAL AND PATIENT-RELATED CONTRIBUTING FACTORS.

Description of Event or Problem

THE CASE INVOLVED A 74-YEAR-OLD MALE WITH A PREVIOUSLY IMPLANTED 26MM CE MAGNA (SAVR, IMPLANTED 2012) WHO PRESENTED WITH VALVE FAILURE DUE TO AORTIC STENOSIS (AS). ON (B)(6), THE PATIENT UNDERWENT A VALVE-IN-VALVE PROCEDURE THAT INCLUDED A DUAL LEAFLET SPLIT USING THE SC DEVICE, FOLLOWED BY AN IMPLANTATION OF A 26MM SAPIEN 3 ULTRA RESILIA WITH A POST-IMPLANT SAVR FRAME FRACTURE. THE OPERATING TEAM DECIDED TO USE A DIFFERENT TYPE OF GW (SOLOPACE (3.0CM H X 2.7CM W) VS. SAFARI S (4.2CM H X 4.2CM W)), WHICH WAS DISCUSSED PRIOR TO THE PROCEDURE. SENTINEL CEREBRAL EMBOLIC PROTECTION DEVICE WAS PLACED AND THE SOLOPACE FUSION GW WAS UTILIZED/OPTIMALLY PLACED IN THE LV. THE SC WAS SUCCESSFULLY ADVANCED THROUGH THE AORTIC ARCH. THE RIGHT LEAFLET WAS TREATED FIRST. INITIAL ATTEMPTS FOR LOCALIZATION AND SPLITTING WER NOT SUCCESSFUL AFTER CONFIRMING THE ABSENCE OF EFFUSION VIA TEE, THE SC WAS DEACTIVATED AND REPOSITIONED. A SECOND ACTIVATION IN AN OPTIMIZED POSITION, CONFIRMED BY FLUORO/ECHO, SUCCESSFULLY COMPLETED THE SPLIT. THE DEVICE WAS REMOVED FROM THE RIGHT LEAFLET IN A CONTROLLED AND PREDICTABLE MANNER, LANDING SLIGHTLY ABOVE THE SAVR FRAME AT THE STJ LEVEL. GW WAS THEN RETRACTED TO THE MID-LEFT VENTRICULAR CAVITY, AND THE DEVICE WAS SAFELY DEACTIVATED AND RE-SHEATHED. FINAL TEE ASSESSMENT CONFIRMED AN OPTIMAL RIGHT LEAFLET SPLIT, WITH THE PATIENT REMAINING HEMODYNAMICALLY STABLE AND NO EVIDENCE OF EFFUSION. FOLLOWING THE RIGHT LEAFLET SPLIT, ATTENTION WAS TURNED TO THE LEFT LEAFLET. THE SC WAS OPTIMALLY POSITIONED AND ACTIVATED OVER THE LEFT LEAFLET UNDER FLUORO/ECHO GUIDANCE. THE SPLIT WAS COMPLETED SUCCESSFULLY AND WITHOUT ISSUE, WITH THE SC DETACHING PREDICTABLY SUPERIOR TO THE SAVR FRAME. FOLLOWING DEACTIVATION AND SHEATHING, TEE CONFIRMED AN OPTIMAL DUAL-LEAFLET SPLIT WITH NO EVIDENCE OF EFFUSION OR HEMODYNAMIC INSTABILITY. THE SC DEVICE WAS SAFELY REMOVED AND EXCHANGED FOR THE SAPIEN TAVR SYSTEM OVER THE SAME SOLOPACE GW. TAVR WAS SUCCESSFULLY DEPLOYED WITHIN THE INDEX SAVR. A POST-DILATION FRAME FRACTURE WAS THEN PERFORMED USING A 26MM TRUE DILATION BALLOON, AFTER WHICH THE PATIENT REMAINED HEMODYNAMICALLY STABLE. FINAL TEE EVALUATION CONFIRMED CORONARY FLOW AND SHOWED NO EVIDENCE OF PERICARDIAL EFFUSION OR AORTIC ARCH DEFECTS. FOLLOWING THE REMOVAL OF THE CEREBRAL EMBOLIC PROTECTION DEVICE, THE PROCEDURE WAS CONCLUDED WITH THE PATIENT IN STABLE CONDITION. ON (B)(6) (8 HOURS POST-OP), THE PATIENT EXPERIENCED CHEST DISCOMFORT. A CT SCAN REVEALED A LOCALIZED INTIMAL FLAP NEAR THE RIGHT INNOMINATE ARTERY AND A THINNED LV WALL/APEX DEFECT. OPERATOR QUESTIONED IF THERE WAS A SMALL/FINE PERFORATION, YET NO APPRECIABLE CONTRAST MEDIUM EXTRAVASATION INTO THE PERICARDIAL SPACE COULD BE CONFIRMED. THE PATIENT UNDERWENT EMERGENCY OPEN-HEART SURGERY THE SAME DAY FOR A 28MM HEMASHIELD GRAFT IN THE ASCENDING AORTA SEGMENT AND A PLEDGETED SUTURE REPAIR AT THE LV APEX. THE OPERATOR NOTED POTENTIAL CONTRIBUTING FACTORS INCLUDING BICUSPID/BOVINE-ANGULATED ARCH ANATOMY, COAGULOPATHY ISSUES, POSSIBLE CONNECTIVE TISSUE DISORDER, AND THE USE OF THE SOLOPACE GW (SUPPORT/WRITE MANIPULATION DIFFERENCES). THE PATIENT IS CURRENTLY RECOVERING.