SHORTCUT

Additional Manufacturer Narrative

THE PATIENT UNDERWENT A SINGLE (LEFT) LEAFLET SPLIT USING THE SHORTCUT, FOLLOWED BY AN IMPLANTATION OF A 23MM SAPIEN 3 ULTRA RESILIA USING THE SAFARI XS GW. A CEREBRAL EMBOLIC PROTECTION DEVICE WAS NOT UTILIZED IN THIS CASE DUE TO SITE PREFERENCE. DURING ADVANCEMENT OF THE SHORTCUT ACROSS THE STENOTIC VALVE, THE PATIENT BECAME HYPOTENSIVE, AND THE DEVICE WAS RETRACTED AND REMOVED. A PRE-BAV USING A 16MM BALLOON WAS SUBSEQUENTLY PERFORMED (UTILIZING RAPID PACING) TO FACILITATE DEVICE TRAVERSAL AND IMPROVE HEMODYNAMIC STABILITY. PATIENT'S HEMODYNAMIC RECOVERY WAS SLOW FOLLOWING THE PACER RUN FROM THE BAV, THEREFORE, MEDICAL MANAGEMENT WAS PROVIDED TO SUPPORT THE PATIENT'S BLOOD PRESSURE. THE SHORTCUT WAS THEN SUCCESSFULLY RE-ADVANCED, POSITIONED, AND ACTIVATED TO PERFORM A LEFT LEAFLET SPLIT. ECHO CONFIRMED GOOD LEAFLET SPLIT FEATURES (INCREASED AI, VISUAL LEAFLET SPLIT). FOLLOWING COMPLETION OF THE LEAFLET SPLIT, THE DEVICE WAS SAFELY REMOVED AND THE 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED (WITH AN ADDITIONAL +2CC'S EXTRA VOLUME) WITHOUT ISSUE. POST-DEPLOYMENT IMAGING CONFIRMED PRESERVED CORONARY FLOW AND APPROPRIATE VALVE POSITION. PER PI-CARDIA'S MEDICAL DIRECTOR'S ASSESSMENT THE PATIENT'S UNDERLYING CLINICAL CONDITION LIKELY REPRESENTED A SIGNIFICANT CONTRIBUTING FACTOR IN THIS EVENT. THE PATIENT WAS DESCRIBED AS CRITICALLY ILL WITH MULTIPLE CO-MORBIDITIES AND LIMITED VENTRICULAR RESERVE. ADDITIONALLY, THE PREVIOUSLY ATTEMPTED BASILICA PROCEDURE WAS ABORTED DUE TO HEMODYNAMIC INSTABILITY, REFLECTING THE PATIENT HAD A COMPROMISED CLINICAL CONDITION PRIOR TO THE INDEX PROCEDURE. DUE TO THE PATIENT'S CLINICAL INSTABILITY, AND VERY POOR CARDIAC RESERVE, HE WAS NOT ABLE TO TOLERATE THE PROLONGED PROCEDURE INCLUDING THE BALLOON PRE-DILATATION WITH RAPID PACING, THE SHORTCUT PROCEDURE WITH ADDITIONAL AORTIC REGURGITATION, AND THE ADDITIONAL RAPID PACING DURING TAVR. POSSIBLY (IN RETROSPECT) SUCH PATIENTS WITH SEVERELY COMPROMISED VENTRICULAR RESERVE SHOULD UNDERGO THIS PROCEDURE WITH CARDIO-PULMONARY SUPPORT. ALTHOUGH A CAUSAL RELATIONSHIP BETWEEN USE OF THE SHORTCUT DEVICE AND THE PATIENT DEATH CANNOT BE DEFINITIVELY EXCLUDED, THE AVAILABLE INFORMATION DOES NOT IDENTIFY A DEVICE MALFUNCTION, MISUSE, OR PROCEDURAL COMPLICATION DIRECTLY ATTRIBUTABLE TO THE DEVICE. THE SHORTCUT DEVICE FUNCTIONED AS INTENDED, INCLUDING SUCCESSFUL POSITIONING, ACTIVATION, LEAFLET SPLITTING, DEACTIVATION, AND REMOVAL. NO DEVICE DEFICIENCIES WERE IDENTIFIED THAT WOULD INDICATE THE DEVICE FAILED TO MEET SPECIFICATIONS. THE EVENT IS CONSIDERED REPORTABLE, SINCE EVEN THOUGH CAUSAL RELATIONSHIP BETWEEN USE OF THE DEVICE AND THE SERIOUS ADVERSE EVENT RESULTING IN PATIENT DEATH IS VERY UNLIKELY IT CANNOT BE COMPLETELY RULED OUT. THE DEVICE FUNCTIONING WAS AS INTENDED BUT THE PRESENCE OF SIGNIFICANT PATIENT-RELATED INSTABILITY WAS THE MAIN CONTRIBUTING FACTOR.

Description of Event or Problem

THE CASE INVOLVED A 75-YEAR-OLD MALE WITH A PREVIOUSLY IMPLANTED 25MM TRIFECTA (SAV) WHO PRESENTED WITH VALVE FAILURE DUE TO AORTIC STENOSIS (AS). THE PATIENT WAS EXTREMELY SICK WITH MULTIPLE CO-MORBIDITIES AND PRESENTED WITH SEVERE MITRAL REGURGITATION. THE PATIENT UNDERWENT A SINGLE (LEFT) LEAFLET SPLIT USING THE SHORTCUT, FOLLOWED BY AN IMPLANTATION OF A 23MM SAPIEN 3 ULTRA RESILIA USING THE SAFARI XS GW. A CEREBRAL EMBOLIC PROTECTION DEVICE WAS NOT UTILIZED IN THIS CASE DUE TO SITE PREFERENCE. DURING ADVANCEMENT OF THE SHORTCUT ACROSS THE STENOTIC VALVE, THE PATIENT BECAME HYPOTENSIVE, AND THE DEVICE WAS RETRACTED AND REMOVED. A PRE-BAV USING A 16MM BALLOON WAS SUBSEQUENTLY PERFORMED (UTILIZING RAPID PACING) TO FACILITATE DEVICE TRAVERSAL AND IMPROVE HEMODYNAMIC STABILITY. PATIENT'S HEMODYNAMIC RECOVERY WAS SLOW FOLLOWING THE PACER RUN FROM THE BAV, THEREFORE, MEDICAL MANAGEMENT WAS PROVIDED TO SUPPORT THE PATIENT'S BLOOD PRESSURE. THE SHORTCUT WAS THEN SUCCESSFULLY RE-ADVANCED, POSITIONED, AND ACTIVATED TO PERFORM A LEFT LEAFLET SPLIT. ECHO CONFIRMED GOOD LEAFLET SPLIT FEATURES (INCREASED AI, VISUAL LEAFLET SPLIT). FOLLOWING COMPLETION OF THE LEAFLET SPLIT, THE DEVICE WAS SAFELY REMOVED AND THE 23MM SAPIEN 3 ULTRA RESILIA VALVE WAS IMPLANTED (WITH AN ADDITIONAL +2CC'S EXTRA VOLUME) WITHOUT ISSUE. POST-DEPLOYMENT IMAGING CONFIRMED PRESERVED CORONARY FLOW AND APPROPRIATE VALVE POSITION. APPROXIMATELY 10 MINUTES POST VALVE DEPLOYMENT AND DURING CLOSING, THE PATIENT BECAME HYPOTENSIVE WITH RAPID DETERIORATION IN GLOBAL HEART FUNCTION OBSERVED ON TEE. CPR, MEDICAL MANAGEMENT, IMPELLA SUPPORT, AND CORONARY ASSESSMENT WERE PERFORMED; HOWEVER, THE PATIENT CONTINUED TO RAPIDLY DECLINE DESPITE INTERVENTION AND EXPIRED INTRA-PROCEDURALLY. AT THE TIME OF COMPLAINT REPORTING, THE EXACT CAUSE OF THE PATIENT'S DETERIORATION AND DEATH HAS NOT BEEN DETERMINED. ON MAY 7, ADDITIONAL INFORMATION REGARDING THE CASE WAS SHARED BY THERAPY DEVELOPMENT. APPROXIMATELY TWO WEEKS PRIOR TO THE SC PROCEDURE, THE PATIENT REPORTEDLY UNDERWENT AN ATTEMPTED BASILICA. THE PROCEDURE WAS REPORTEDLY POORLY TOLERATED DUE TO HEMODYNAMIC INSTABILITY AND THEREFORE ABORTED. POST-PROCEDURE THE PATIENT WAS UNSTABLE WHICH CAUSE A PROLONGED HOSPITALIZATION AND LATE PATIENT DISCHARGE.