SHORTCUT

Description of Event or Problem

DURING THE PLANNED VALVE-IN-VALVE (VIV) PROCEDURE IN A HIGH SURGICAL RISK PATIENT, A SHORTCUT DEVICE WAS USED FOR A SINGLE RC LEAFLET SPLIT DUE TO RISK OF CORONARY OBSTRUCTION. THE PATIENT, A (B)(6) YEAR-OLD FRAIL FEMALE WITH STRUCTURAL VALVE DETERIORATION, MANIFESTING AS BOTH AORTIC STENOSIS (AS) AND AORTIC REGURGITATION (AR) IN A PREVIOUSLY IMPLANTED 23 MM SAPIEN 3 VALVE, ALSO PRESENTED WITH A PRE-EXISTING HYPERTROPHIC HEART AND A TRACE-TO-MILD PERICARDIAL EFFUSION. THE PROCEDURE WAS INITIATED AS PLANNED. WHILE ADVANCING THROUGH THE DESCENDING AORTA AND INTO THE ARCH, THE GW INITIALLY APPEARED WELL POSITIONED IN THE LV APEX BUT SUBSEQUENTLY PROLAPSED, REQUIRING REPOSITIONING WITH TRACTION APPLIED BY THE SECOND OPERATOR UNDER PHYSICIAN INSTRUCTION TO FACILITATE TRAVERSAL OF THE ARCH. THE SHORTCUT WAS ADVANCED OVER A SAFARI SMALL GUIDEWIRE. AFTER CROSSING THE ARCH, THE DEVICE WAS UNSHEATHED AND MANIPULATED TOWARD THE RC LEAFLET. AT THAT POINT, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE, AND ECHOCARDIOGRAPHY SHOWED PROGRESSION OF A PRE-EXISTING PERICARDIAL EFFUSION. THE PA APPEARED TO REORIENT MORE ANTERIORLY AND BECAME ENGAGED AT THE RC/LC COMMISSURE OF THE S3 FRAME. ADDITIONAL FLEXION WAS APPLIED TO DIRECT THE DEVICE AWAY FROM THE COMMISSURE, ALLOWING THE PA TO DESCEND INTO APPROPRIATE POSITION ON THE RC LEAFLET. THE ANESTHESIA TEAM REPORTED THAT LV FUNCTION APPEARED ABNORMAL, WITH A REDUCTION IN CONTRACTILITY OBSERVED. TWO ACTIVATION ATTEMPTS WERE MADE, BUT CORRECT POSITIONING OF THE SPLITTING ELEMENT COULD NOT BE CONFIRMED. THE PATIENT DEVELOPED TAMPONADE REQUIRING CPR AND PERICARDIOCENTESIS WITH EVACUATION OF A LARGE BLOODY EFFUSION. THE PROCEDURE WAS ABORTED, AND THE DEVICE WAS RE-SHEATHED AND WITHDRAWN. SUSPECTED LV PERFORATION WAS NOTED, AND CPR AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE THE BLOOD. AFTER THE PATIENT WAS STABILIZED, CLOTS WERE REMOVED FROM THE RIGHT ARTIUM, AND THE PATIENT WAS MOVED TO THE ICU WITH A DRAIN. PI-CARDIA WAS INFORMED BY THE CLINICAL SITE ON THE DAY FOLLOWING THE PROCEDURE THAT THE PATIENT HAD PASSED AWAY. NO ADDITIONAL DETAILS REGARDING THE EXACT TIMING OR SPECIFIC CIRCUMSTANCES OF DEATH WERE PROVIDED.

Additional Manufacturer Narrative

THE PROCEDURE WAS INITIATED AS PLANNED. WHILE ADVANCING THROUGH THE DESCENDING AORTA AND INTO THE ARCH, THE GW INITIALLY APPEARED WELL POSITIONED IN THE LV APEX BUT SUBSEQUENTLY PROLAPSED, REQUIRING REPOSITIONING WITH TRACTION APPLIED BY THE SECOND OPERATOR UNDER PHYSICIAN INSTRUCTION TO FACILITATE TRAVERSAL OF THE ARCH. THE SHORTCUT WAS ADVANCED OVER A SAFARI SMALL GUIDEWIRE. AFTER CROSSING THE ARCH, THE DEVICE WAS UNSHEATHED AND MANIPULATED TOWARD THE RC LEAFLET. AT THAT POINT, THE PATIENT BECAME HEMODYNAMICALLY UNSTABLE, AND ECHOCARDIOGRAPHY SHOWED PROGRESSION OF A PRE-EXISTING PERICARDIAL EFFUSION. THE PA APPEARED TO REORIENT MORE ANTERIORLY AND BECAME ENGAGED AT THE RC/LC COMMISSURE OF THE S3 FRAME. ADDITIONAL FLEXION WAS APPLIED TO DIRECT THE DEVICE AWAY FROM THE COMMISSURE, ALLOWING THE PA TO DESCEND INTO APPROPRIATE POSITION ON THE RC LEAFLET. THE ANAESTHESIA TEAM REPORTED THAT LV FUNCTION APPEARED ABNORMAL, WITH A REDUCTION IN CONTRACTILITY OBSERVED. TWO ACTIVATION ATTEMPTS WERE MADE, BUT CORRECT POSITIONING OF THE SPLITTING ELEMENT COULD NOT BE CONFIRMED. THE PATIENT DEVELOPED TAMPONADE REQUIRING CPR AND PERICARDIOCENTESIS WITH EVACUATION OF A LARGE BLOODY EFFUSION. THE PROCEDURE WAS ABORTED, AND THE DEVICE WAS RE-SHEATHED AND WITHDRAWN. SUSPECTED LV PERFORATION WAS NOTED, AND CPR AND PERICARDIOCENTESIS WAS PERFORMED TO REMOVE THE BLOOD. AFTER THE PATIENT WAS STABILIZED, CLOTS WERE REMOVED FROM THE RIGHT ARTIUM, AND THE PATIENT WAS MOVED TO THE ICU WITH A DRAIN. PI-CARDIA WAS INFORMED BY THE CLINICAL SITE ON THE DAY FOLLOWING THE PROCEDURE THAT THE PATIENT HAD PASSED AWAY. NO ADDITIONAL DETAILS REGARDING THE EXACT TIMING OR SPECIFIC CIRCUMSTANCES OF DEATH WERE PROVIDED. THE SHORTCUT DEVICE USED DURING THE PROCEDURE WAS NOT RETURNED TO PI-CARDIA FOR INVESTIGATION DUE TO INTERNAL HOSPITAL POLICY. THEREFORE, A DIRECT DEVICE INSPECTION COULD NOT BE PERFORMED. THE INVESTIGATION RELIED ON INFORMATION PROVIDED BY THE INFORMATION FROM HOSPITAL PROCEDURAL SUMMARY AND PI-CARDIA'S TD TEAM MEMBERS WHO WERE PRESENT DURING THE PROCEDURE. A LIMITED INVESTIGATION WAS UNDERTAKEN, WHICH INCLUDED REVIEW OF TRAINING RECORDS, PROCEDURE SUMMARY, AND THE DEVICE HISTORY RECORD (DHR). PI-CARDIA REP CONFIRMED THAT DURING THE PREPARATION OF THE DEVICE IT WAS STRUCTURALLY INTACT AND FUNCTIONING APPROPRIATELY WITH NO EVIDENCE OF MANUFACTURING OR RELEASE-RELATED ISSUES. PER THE CASE RECORDS AND INVESTIGATION FINDINGS, THE PERFORATION WAS POSSIBLY RELATED TO GUIDEWIRE MANIPULATIONS DURING ADVANCEMENT THROUGH THE DESCENDING AORTA AND ARCH, WHEN THE WIRE PROLAPSED FROM THE LV APEX AND REQUIRED REPOSITIONING WITH TRACTION. THE PROCEDURE WAS PERFORMED BY A TRAINED PHYSICIAN ASSISTED BY UNTRAINED LAB TECHNICIAN. THE WIRE, WHICH HAD INITIALLY APPEARED WELL POSITIONED IN THE LV APEX, SUBSEQUENTLY PROLAPSED AND REQUIRED TRACTION AND REPOSITIONING. THESE WIRE MANIPULATIONS WERE PERFORMED BY THE UNTRAINED LAB TECHNICIAN, MAY HAVE RESULTED IN EXCESSIVE WIRE PRESSURE WITHIN THE VENTRICLE WHICH COULD INCREASE THE RISK OF PERFORATION, PARTICULARLY IN THE CONTEXT OF THE PATIENT'S STRUCTURALLY VULNERABLE HEART. THE INSTRUCTIONS FOR USE SPECIFY THAT THE SHORTCUT IS INTENDED FOR USE BY TRAINED INTERVENTIONAL CARDIOLOGISTS OR CARDIAC SURGEONS. IN THIS CASE, GUIDEWIRE MANIPULATIONS WERE PERFORMED BY A LAB TECHNICIAN WHO HAD NOT RECEIVED SHORTCUT TRAINING. THE QUALIFIED PHYSICIAN OPERATOR WAS APPROPRIATELY TRAINED, BUT DUE TO THE ABSENCE OF TRAINED ASSISTANTS, THE TECHNICIAN WAS ENGAGED IN A SUPPORTING ROLE. LV PERFORATION IS A KNOWN PROCEDURAL RISK IN STRUCTURAL HEART INTERVENTIONS ASSOCIATED WITH GUIDE WIRE MANIPULATION, INCLUDING TAVR. THE DEVICE'S DESIGN, INSTRUCTIONS FOR USE, AND PHYSICIAN TRAINING ADDRESS SUCH RISKS. AS IN TAVR PROCEDURES, CAREFUL ATTENTION TO WIRE MANIPULATION IS CRITICAL TO PREVENT COMPLICATIONS LIKE LEFT VENTRICULAR (LV) PERFORATION. BASED ON THE INVESTIGATION, THE RESIDUAL RISK REMAINS ACCEPTABLE, AND NO ADDITIONAL RISK CONTROLS ARE REQUIRED.