BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2980711 · Received February 27, 2013

    Report

    Report Number
    2015691-2013-19400
    Event Type
    Injury
    Date Received
    February 27, 2013
    Date of Event
    February 11, 2013
    Report Date
    February 11, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AS IT REMAINS IMPLANTED IN THE PATIENT. PER THE INSTRUCTIONS FOR USE, ARRHYTHMIAS AND CORONARY OBSTRUCTION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. THERE ARE SEVERAL PATIENT FACTORS WHICH COULD CONTRIBUTE TO A CORONARY OBSTRUCTION, INCLUDING A MINIMAL DISTANCE BETWEEN THE NATIVE ANNULUS AND THE CORONARY OSTIA, BULKY CALCIFICATION, LONG NATIVE LEAFLETS, OBLITERATED CORONARY SINUSES, AND THROMBUS. IN ADDITION, PROCEDURAL FACTORS SUCH AS DEPLOYMENT OF THE BIOPROSTHETIC HEART VALVE TOO AORTIC AND SIGNIFICANT VALVE OVER SIZING COULD ALSO CONTRIBUTE. PATIENTS UNDERGOING TAVR MAY BE NON-OPERATIVE AND/OR ARE EXTREMELY HIGH RISK AND HAVE COMPLEX MEDICAL HISTORIES AND MULTIPLE CO-MORBIDITIES. THEY ARE ROUTINELY ADMINISTERED MULTIPLE VASOACTIVE DRUGS DURING THE PROCEDURE AND ARE PURPOSELY MADE HYPOTENSIVE, UTILIZING EXTREME TACHYCARDIA (BY MEANS OF RAPID VENTRICULAR PACING), TO FACILITATE ACCURATE VALVE DEPLOYMENT. AS A RESULT OF THESE FACTORS, INTRA-OPERATIVE ARRHYTHMIAS ARE VERY COMMON DURING THE TAVR PROCEDURE. IN SOME CASES, RAPID PACING CAN INDUCE VENTRICULAR FIBRILLATION. IN THIS CASE, THE IMPLANTING PHYSICIAN REPORTED THAT THE CORONARY OCCLUSIONS RESULTED FROM THE PATIENT NOT BEING PROPERLY HEPARINIZED. IT IS LIKELY THAT THE VT WAS DUE TO A COMBINATION OF PROCEDURAL FACTORS (RAPID PACING AND CORONARY OCCLUSION RESULTING FROM THE PATIENT NOT BEING HEPARINIZED PROPERLY). THE IFU AND TRAINING MANUALS HAVE BEEN REVIEWED AND NO INADEQUACIES HAVE BEEN IDENTIFIED WITH REGARDS TO WARNINGS, CONTRAINDICATIONS, AND THE DIRECTIONS/CONDITIONS FOR THE SUCCESSFUL USE OF THE DEVICE. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS, AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS PART OF THIS MONTHLY REVIEW. NO CORRECTIVE OR PREVENTATIVE ACTIONS ARE REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED BY THE EDWARDS FIELD CLINICAL SPECIALIST, THE PATIENT EXPERIENCED AN OCCLUSION OF THE RIGHT AND LEFT CORONARY ARTERIES FOLLOWING DEPLOYMENT OF A 23MM SAPIEN VALVE, WHICH REQUIRED THE IMPLANTATION OF STENTS IN THE LEFT CORONARY ARTERY. THE PATIENT ALSO DEVELOPED VENTRICULAR TACHYCARDIA (VT) DURING THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. CASE SUMMARY: THE APEX WAS OPENED AND THE SHEATH WAS INSERTED WITHOUT DIFFICULTY. HEPARIN WAS ADMINISTERED PRIOR TO THE SHEATH INSERTION AND THE MEDICAL TEAM THEN WAITED FOR THE ACT RESULTS BEFORE PROCEEDING WITH BALLOON AORTIC VALVULOPLASTY (BAV). THE INITIAL ACT CAME BACK AT 120 SECONDS SO ADDITIONAL HEPARIN WAS ADMINISTERED. THE SECOND ACT CAME BACK AT 105 SECONDS. THE MEDICAL TEAM TRIED TO DRAW A SAMPLE FROM THE VENOUS SHEATH AND NOTED THAT THE SHEATH HAD THROMBUS. THEY WITHDREW THE PACING CATHETER AND SHEATH, INSERTED A NEW SHEATH, THEN REINSERTED AND TESTED THE TEMPORARY PACER. THE MEDICAL TEAM SUSPECTED THAT THE HEPARIN WAS NOT ACTUALLY GETTING TO THE PATIENT SO ADDITIONAL HEPARIN WAS GIVEN VIA A DIFFERENT PORT. A THIRD ACT SAMPLE WAS DRAWN AND THIS ONE WAS ABOVE 300 SECONDS. THE TEAM THEN INSERTED THE EDWARDS 3CM X 20MM BAV CATHETER AND PERFORMED BAV UNDER RAPID VENTRICULAR PACING (RVP). THE PATIENT RAPIDLY RETURNED TO BASELINE FOLLOWING VALVULOPLASTY SO THE SAPIEN VALVE ON THE ASCENDRA CATHETER WAS INSERTED. THERE WAS MODERATE TO SEVERE AORTIC INSUFFICIENCY WITH THE SAPIEN VALVE ACROSS THE NATIVE VALVE AND THE PATIENT REQUIRED EPINEPHRINE.. THE SAPIEN VALVE WAS DEPLOYED 50:50 DURING RVP AND THE PATIENT RECOVERED QUICKLY. THE PATIENT'S BLOOD PRESSURE THEN ROSE RAPIDLY TO ABOVE 200 SYSTOLIC, SO PACING WAS INITIATED TO CONTROL THE BLOOD PRESSURE. THE PATIENT'S BLOOD PRESSURE THEN DROPPED AS RAPIDLY AS IT ROSE SO PACING WAS STOPPED AND A RAPID ASSESSMENT WAS PERFORMED. THERE WAS NO AORTIC INSUFFICIENCY OR BLOOD IN THE PERICARDIAL SPACE. A ROOT AORTOGRAM REVEALED THAT BOTH THE LEFT AND RIGHT CORONARIES WERE COMPLETELY OCCLUDED. THE SAPIEN VALVE WAS WELL BELOW THE CORONARY OSTIA. AND THE NATIVE LEAFLETS DID NOT APPEAR TO BE COVERING THE CORONARY OSTIA. CARDIOPULMONARY BYPASS (CPB) WAS RAPIDLY INITIATED AND CHEST COMPRESSIONS WERE PERFORMED. THE TEAM THEN WORKED TO RESTORE CORONARY BLOOD FLOW. MULTIPLE STENTS WERE PLACED IN THE LEFT CORONARY SYSTEM. AN ANGIOGRAM WAS THEN TAKEN OF THE RIGHT CORONARY REVEALING THAT BLOOD FLOW WAS ALREADY BACK TO NEARLY NORMAL WITHOUT INTERVENTION. THERE WERE MULTIPLE EPISODES OF VENTRICULAR TACHYCARDIA, WHICH REQUIRED DEFIBRILLATION. THE PATIENT WAS THEN WEANED OFF OF BYPASS AND A BALLOON PUMP WAS INSERTED. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU) IN CRITICAL CONDITION. THE PATIENT WAS NOTED TO BE EXTUBATED AND DOING WELL ON THE DAY FOLLOWING THE PROCEDURE. PER THE IMPLANTING THE PHYSICIAN, THE CORONARY OCCLUSION RESULTED FROM THE PATIENT NOT BEING HEPARINIZED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84269 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE NPT EDWARDS LIFESCIENCES 9000TFX23A

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Required Intervention