Description of Event or Problem · 1
AN (B)(6) MALE WITH CRITICAL AORTIC STENOSIS AND MULTIPLE COMORBIDITIES WAS TAKEN FOR ELECTIVE TRANSCATHETER AORTIC VALVE REPLACEMENT (TVAR) PROCEDURE. THERE WAS A PROBLEM DEPLOYING THE BALLOON (DUE TO BALLOON RUPTURE) AND THE PT SUFFERED A CARDIAC ARREST. WE WERE UNABLE TO RESUSCITATE HIM. FROM THE PHYSICIANS PROCEDURE REPORT(AVAILABLE TO FDA IF NEEDED): DURING THE PROCEDURE, WHEN THE BALLOON WITH THE VALVE ON IT WAS IN POSITION ACROSS THE STENOTIC AORTIC VALVE AND THEY WENT TO DEPLOY THE VALVE BY INFLATING THE DELIVERY BALLOON, THEY NOTED THAT THE PROXIMAL PORTION OF THE VALVE DELIVERY BALLOON DID NOT INFLATE ALTHOUGH THE DISTAL PORTION HAD STARTED TO INFLATE. THIS LEFT THE REPLACEMENT VALVE PARTIALLY DEPLOYED IN THE PT'S DISEASED AORTIC VALVE AREA CAUSING IMMEDIATE AORTIC INSUFFICIENCY. THE PT BECAME HEMODYNAMICALLY UNSTABLE AND REQUIRED REPEATED DEFIBRILLATION FOR VENTRICULAR TACHYCARDIA. AFTER HAVING DIFFICULTY REMOVING THE UNDER-DEPLOYED VALVE AND RUPTURED DELIVERY BALLOON, THE PT CONTINUED TO DETERIORATE AND WAS ULTIMATELY UNABLE TO BE RESUSCITATED. PROCEDURE REPORTS ARE AVAILABLE UPON REQUEST. TEMPORARY PACEMAKER ST JUDE DIAGNOSTIC DIVISION 5FR BALLOON TIP, TEMPORARY PACING CATHETER # (B)(4) USED DURING PROCEDURE AS WELL AS VASCULAR ACCESS DEVICES.