SHORTCUT

Additional Manufacturer Narrative

DURING THE PLANNED VALVE-IN-VALVE (VIV) PROCEDURE IN A HIGH-RISK PATIENT, A SHORTCUT DEVICE WAS USED FOR A DUAL LEAFLET SPLIT DUE TO HIGH RISK TO CORONARY OBSTRUCTION. THE PATIENT, A (B)(6) FEMALE WITH PREVIOUSLY IMPLANTED 23 MM MITROFLOW (2016) BY SAVR WITH HEAVILY CALCIFIED AORTIC VALVE, FAILING DUE TO SEVERE AORTIC STENOSIS (AS) AND MITRAL REGURGITATION (MR), ALSO PRESENTED WITH A PRE-EXISTING HYPERTROPHIC AND SMALL LEFT VENTRICLE STRUCTURE. THE PROCEDURE WAS INITIATED AS PLANNED. THE PROCEDURE WAS CLINICALLY CHALLENGING DUE TO THE PRESENCE OF HEAVILY CALCIFIED LEAFLETS, WHICH REQUIRED PROLONGED ATTEMPTS TO ACHIEVE EFFECTIVE SPLITTING. EACH LEAFLET SPLIT INVOLVED APPROXIMATELY 20 MINUTES OF SUSTAINED GUIDEWIRE MANIPULATION, INCLUDING REPEATED PUSH-PULL TECHNIQUES AS DESCRIBED IN THE IFU. AFTER REPOSITIONING TOWARD THE RC LEAFLET, THE PHYSICIAN OBSERVED A BRIEF RUN OF VENTRICULAR TACHYCARDIA WITH SLIGHT ST-SEGMENT CHANGES; THE PROCEDURE WAS PAUSED FOR ASSESSMENT, BUT NO ABNORMALITIES WERE IDENTIFIED, AND THE PATIENT REMAINED STABLE. SPLITTING OF THE RC LEAFLET REQUIRED AN ADDITIONAL 15 MINUTES AND WAS ULTIMATELY COMPLETED, WITH BOTH SPLITS CONFIRMED BY ECHOCARDIOGRAPHY. THE DEVICE WAS RE-SHEATHED, WITHDRAWN, AND FOUND TO BE FUNCTIONING AS INTENDED. DURING SUBSEQUENT TAVI PROCEDURE, A GRADUAL DECLINE IN BLOOD PRESSURE WAS NOTED DURING THE VALVE DEPLOYMENT. CORONARY CONTRAST INJECTION SHOWED ADEQUATE FLOW, BUT LV PERFORATION AT THE APICAL REGION WAS LATER IDENTIFIED, PROMPTING PERICARDIAL DRAINAGE, AFTER WHICH THE PATIENT STABILIZED. FOLLOWING CONSULTATION WITH THE PATIENT'S FAMILY, A DECISION WAS MADE TO PROCEED WITH OPEN-HEART SURGERY TO REPAIR THE LV PERFORATION. ACCORDING TO THE MOST RECENT UPDATE, THE PATIENT IS RECOVERING FOLLOWING THE SURGICAL PROCEDURE. THE SHORTCUT DEVICE USED DURING THE PROCEDURE WAS NOT RETURNED TO PI-CARDIA, AS POST-PROCEDURE EVALUATION CONFIRMED THAT IT WAS FULLY OPERATIONAL WITH NO SIGNS OF BREAKAGE, ABNORMAL BEHAVIOR, OR MECHANICAL FAILURE, THEREFORE DEVICE WAS DISCARDED BY THE HOSPITAL. THE INVESTIGATION WAS BASED ON INFORMATION PROVIDED BY THE TD TEAM MEMBERS WHO WERE PRESENT DURING THE PROCEDURE, AS WELL AS FLUOROSCOPY VIDEOS MADE AVAILABLE TO PI-CARDIA. A COMPREHENSIVE REVIEW WAS CONDUCTED, INCLUDING EVALUATION OF THE PATIENT'S ANATOMY, TRAINING RECORDS, FLUOROSCOPY VIDEO, PROCEDURE SUMMARY, AND DEVICE HISTORY RECORD (DHR). THE DEVICE AND MANUFACTURING BATCH RECORD INVESTIGATION REVEALED NO EVIDENCE OF COMPONENT-RELATED ISSUES THAT COULD BE LINKED TO THE REPORTED COMPLAINT OR HAVE CONTRIBUTED TO THE FAILURE. ALTHOUGH ALL PATIENT'S ANATOMICAL PARAMETERS WERE WITHIN THE ACCEPTABLE RANGE, BOTH THE LC AND RC LEAFLETS WERE HEAVILY CALCIFIED. IN ADDITION, THE LV CAVITY WAS NARROW DUE TO HYPERTROPHY. THESE FACTORS RESULTED IN CHALLENGING SPLITTING OF BOTH LEAFLETS (~20 MIN EACH), WHICH REQUIRED MULTIPLE MANIPULATIONS OF THE GUIDEWIRE. PER PI-CARDIA MEDICAL DIRECTOR ASSESSMENT, THE LV PERFORATION MECHANISM IN THIS CASE WAS PROGRESSIVE APICAL EROSION RATHER THAN AN INSTANTANEOUS PUNCTURE. REVIEW OF THE FLUOROSCOPY IMAGES PROVIDED BY THE TD TEAM CONFIRMS THAT THE WIRE HAD BEEN POSITIONED DEEP WITHIN THE LV DURING THE RC LEAFLET SPLIT- INSTEAD OF BEING FREE IN THE CAVITY, THE WIRE MADE PERSISTENT CONTACT WITH THE ENDOCARDIUM AT THE APEX. THE WIRE APPEARS TO HAVE ACTED AS A 'FIXED POINT' AGAINST THE APEX, CREATING INITIAL ENDOCARDIAL EROSION THAT LIKELY TRIGGERED THE VENTRICULAR ARRHYTHMIA. AT THIS POINT THE INJURY HAD NOT YET PENETRATED THE FULL MYOCARDIUM AND THE PATIENT REMAINED HEMODYNAMICALLY STABLE. CONTINUED PUSH-PULL TECHNIQUE WAS APPLIED AND EXTRA FORCE WAS USED TO COMPLETE THE SPLIT, WHICH WAS TRANSMITTED ALONG THE WIRE, GRADUALLY PROPAGATING THE INJURY. THIS PRODUCED A SLOW INTRAMYOCARDIAL EROSION TRACK WITH LIMITED HEMATOMA AND PROBABLY A SMALL PERICARDIAL EFFUSION, RESULTING IN PROGRESSIVE - NOT ABRUPT COLLAPSE - BLOOD PRESSURE DETERIORATION. THE LV CONTRAST INJECTION (GENERALLY AVOIDED IN THIS CONTEXT) MAY HAVE CONVERTED A CONTAINED EROSION INTO A FULL PERFORATION: THE ABRUPT RISE IN LV PRESSURE DURING CONTRAST ADMINISTRATION CAN TRANSFORM A CONFINED EROSION INTO A COMPLETE FREE-WALL RUPTURE WITH RAPID TAMPONADE. THERE WAS NO INDICATION THAT THE DEVICE CAUSED THE LV PERFORATION. IT IS LIKELY THAT THE GW WAS THE CAUSE OF THE EVENT, HOWEVER, WHILE NO DEVICE MALFUNCTION OCCURRED, THE SHORTCUT WAS ACTIVELY IN USE AT THE TIME OF THE EVENT, AND A CAUSAL RELATIONSHIP TO THE OUTCOME CANNOT BE DEFINITIVELY EXCLUDED.

Description of Event or Problem

A 89 YEAR-OLD FEMALE WITH PREVIOUSLY IMPLANTED 23 MM MITROFLOW (2016) BY SARV WITH HEAVILY CALCIFIED AORTIC VALVE, FAILING DUE TO SEVERE AORTIC STENOSIS (AS) AND MITRAL REGURGITATION (MR). THE PROCEDURE PLAN INCLUDED A DUAL SPLIT PRIOR TO IMPLANTATION OF A 23 MM EVOLUT FX+. THE SHORTCUT DEVICE WAS INTRODUCED AND ADVANCED OVER A SAFARI SMALL GUIDEWIRE (GW). LC LEAFLET SPLIT WAS COMPLETED SUCCESSFULLY, USING THE GOOD PUSH AND PULL TECHNIQUES. THE SPLIT WAS SUCCESSFULLY COMPLETED AFTER 20 MINUTES AND THE DEVICE WAS ROTATED TO RC LEAFLET TO BEGIN SPLITTING PROCESS. AFTER 5 MINUTES OF UNSUCCESSFUL ATTEMPTS TO SPLIT WITH PUSH AND PULL TECHNIQUES THE PHYSICIAN PAID ATTENTION FOR APPEARANCE OF VENTRICULAR TACHYCARDIA (VT) AND A SLIGHT CHANGE IN ST ELEVATION. AFTER ASSESSING PATIENT PARAMETERS AND TAKING INTO CONSIDERATION THAT PATIENT WAS STABLE UP TO THIS POINT, THE TEAM DECIDED TO CONTINUE THE PROCEDURE. AFTER ADDITIONAL 15 MINUTES OF ATTEMPTS THE RC LEAFLET WAS SUCCESSFULLY COMPLETED. RC LEAFLET WAS IDENTIFIED AS HEAVILY CALCIFIED MULTIPLE PUSH AND PULL FORCES WERE REQUIRED TO COMPLETE THE SPLIT. BOTH SPLITS WERE CONFIRMED ON THE ECHO DURING THE PROCEDURE AND THE PATIENT WAS STABLE UP TO THIS POINT. DURING THE DEPLOYMENT OF EVOLUT FX+ THE ANAESTHESIA REPORTED FOR A DROP IN PRESSURE. THE EVOLUT WAS SUCCESSFULLY IMPLANTED AND THE TEAM BEGAN TO INVESTIGATE THE PRESSURE. LV PERFORATION IN THE APICAL SIDE OF LV WAS IDENTIFIED. THE PERICARDIAL SYNTHESIS WAS PERFORMED AND PATIENT WAS STABILIZED. THE TEAM PROCEEDED WITH OPEN HEART SURGERY TO FIX THE LV PERFORATION THAT WAS FOUND, AND THE PATIENT WAS STABLE AFTER PROCEDURE. PATIENT RECOVERING AFTER THE SURGERY.