SHORTCUT

Description of Event or Problem

THE CASE INVOLVED A 74-YEAR OLD FEMALE WITH A PREVIOUS 23MM SAPIEN 3 ULTRA RESILIA (S3U) VALVE FAILING FROM AS. A SINGLE LCA SPLIT WAS PLANNED PRIOR TO IMPLANTING A 23MM S3UR VALVE. PRIOR TO SHORTCUT LEAFLET MODIFICATION AND THE NEW SAPIEN VALVE IMPLANT, THE OPERATOR PERFORMED A SELECTIVE LEFT CORONARY ARTERY ANGIOGRAM FOR INSPECTION TO ASSESS POTENTIAL TAVR INDUCED CORONARY OBSTRUCTION RISK AND CONSIDERATION FOR PRE-PROTECTION. THE OPERATOR FELT THE RISK APPEARED LOW. THE SHORTCUT AND NEW SAPIEN TAVR IMPLANT (PRIOR TO POST BAV) PROCEDURE WERE PERFORMED AS PLANNED WITH FLUORO/TEE GUIDANCE. ACT REMAINED >250MS. SIGNIFICANT LEFT LEAFLET CALCIUM WAS OBSERVED IN THE DIRECTION OF THE LCA/COMMISSURE AREA AND WAS AVOIDED. THE LEFT LEAFLET SPLIT TOOK APPROXIMATELY 14 MINUTES FOLLOWED BY A CALCULATED SLIGHTLY LOWER IMPLANT DEPTH DEPLOYMENT (FROM TOP OF INDEX VALVE) OF THE NEW S3 IMPLANT. THE PATIENT REMAINED STABLE WITH NO ECG CHANGES OR HYPOTENSION UP TO THIS POINT IN THE PROCEDURE. POST- VALVE DEPLOYMENT, THE PATIENT'S CARDIAC PRESSURES WERE ELEVATED, AND WERE MANAGED MEDICALLY. AS THE PATIENT WAS HEMODYNAMICALLY STABLE, THE TEAM DISCUSSED PERFORMING POST DILATING (BAV) WITH THE ORIGINAL BALLOON (22 MM EDW COMPLIANT) AND ADD 1CC OF EXTRA VOLUME TO OPTIMIZE FRAME EXPANSION. AT THIS POINT, APPROXIMATELY 5-10 MINUTES FOLLOWING THE INITIAL VALVE DEPLOYMENT A TESTING RUN OF RAPID PACING ENSUED WHICH WAS SUCCESSFUL WITH GOOD CAPTURE AND A TYPICAL HEMODYNAMIC RESPONSE AND RECOVERY. THE POST BAV WAS THEN PERFORMED AS PLANNED, THE PACING RUN ENDED AND THE PATIENT'S PRESSURES INITIALLY STARTED TO RISE (SLOWLY), HOWEVER ECG RHYTHM CHANGES/V TACH OCCURRED. EFFUSION WAS RULED OUT BY ECHO. THE PATIENT UNDERWENT IMMEDIATE CARDIOVERSION, PULSE PRESSURES WERE WEAK AND CPR/MEDICAL MANAGEMENT WERE PROVIDED. SELECTIVE LEFT CORONARY ANGIOGRAM WAS PERFORMED WHICH REVEALED POSSIBLE EMBOLIZED MATERIAL (UNCLEAR WHETHER CLOT OR CALCIUM) WITHIN THE MID LAD REGION. THEREFORE, THIS SEGMENT WAS BALLOONED AND STENTED. THE LEFT MAIN, PROXIMAL LAD AND CIRCUMFLEX SEGMENTS WERE PATENT AND WITHOUT NEED FOR INTERVENTION. THE PATIENT WAS PUT ON ECMO AND BALLOON PUMP FOR CARDIAC SUPPORT. AN ADDITIONAL ECHO CHECK DID NOT REVEAL ANY EFFUSION. AFTER COMPLETION OF THE PROCEDURE, THE PATIENT WAS TRANSFERRED TO THE CICU.

Additional Manufacturer Narrative

POST-VALVE IMPLANT, THE PATIENT'S BP ELEVATED AND WAS MANAGED MEDICALLY. AS THE PATIENT STABILIZED, BAV WAS PERFORMED IN ORDER TO OPTIMIZE FRAME EXPANSION, HOWEVER RHYTHM CHANGES WERE NOTED BY ECG AND THE PATIENT UNDERWENT CARDIOVERSION AND CPR. SELECTIVE LEFT CORONARY ANGIOGRAM REVEALED A POSSIBLE EMBOLIZED MATERIAL (UNKNOWN WHETHER A CLOT OR CALCIFIC MATERIAL) WAS NOTICED WITHIN THE MID LAD REGION, WHICH WAS BALLOONED AND STENTED. THE PROXIMAL LAD, LM, AND CX REMINED PATENT AND WITHOUT NEED FOR INTERVENTION. THE PATIENT WAS FINALLY PUT ON ECMO AND BALLOON PUMP FOR CARDIAC SUPPORT AND WAS TRANSFERRED TO CICU. FOLLOWING THE PROCEDURE THE DEVICE WAS INSPECTED BY THE PI-CARDIA TEAM AND WAS FOUND TO BE FUNCTIONAL. PER MEDICAL DIRECTOR ASSESSMENT, THE EMBOLIZED MATERIAL COULD REPRESENT EMBOLIZATION OF CALCIUM (FROM VALVE TISSUE) OR THROMBUS (FROM THE BALLOON USED FOR POST-DILATATION OR FROM A CLOT FORMED AROUND THE COMPRESSED VALVE IN THE SINUS THAT WAS MOBILIZED BY THE POST-DILATATION). THIS CORONARY OBSTRUCTION DIFFERS FROM PREVIOUS CORONARY OBSTRUCTION CASES REPORTED IN THE COMMERCIAL PHASE, AS THE OBSTRUCTION WAS DUE TO EMBOLUS AND OCCURRED IN THE MID LAD, RATHER THAN THE CORONARY OSTIUM. THE VENTRICULAR TACHYCARDIA IS ASSUMED TO BE SECONDARY TO ISCHEMIA. IMPORTANTLY, THE DEVICE PERFORMED AS INTENDED THROUGHOUT THE CLINICAL PROCEDURE, WITH NO EVIDENCE OF MALFUNCTION IDENTIFIED. DUE TO THE COMPLEXITY OF THE CLINICAL PRESENTATION AND UNCERTAINTY REGARDING THE EXACT ETIOLOGY OF THE EMBOLIC EVENT, THE CASE UNDERWENT ADDITIONAL INTERNAL MEDICAL AND REGULATORY ASSESSMENT, INCLUDING FURTHER REVIEW WITH THE MEDICAL DIRECTOR. ALTHOUGH THE EVENT IS CONSIDERED UNLIKELY TO BE DIRECTLY RELATED TO THE SHORTCUT PROCEDURE ITSELF, A CAUSAL CONTRIBUTION OF THE DEVICE AND/OR PROCEDURE CANNOT BE DEFINITIVELY RULED OUT. BASED ON THIS REASSESSMENT AND IN ACCORDANCE WITH A CONSERVATIVE INTERPRETATION OF FDA MEDICAL DEVICE REPORTING REQUIREMENTS UNDER 21 CFR PART 803, THE COMPLAINT WAS DETERMINED TO MEET THE CRITERIA FOR REPORTABILITY AND WAS THEREFORE SUBMITTED AS A 30-DAY MDR EVENT.