BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 3041511 · Received April 8, 2013

    Report

    Report Number
    2015691-2013-19767
    Event Type
    Injury
    Date Received
    April 8, 2013
    Date of Event
    March 14, 2013
    Report Date
    March 14, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    NPT
    PMA / PMN Number
    P110021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PER THE INSTRUCTIONS FOR USE (IFU), ARRHYTHMIAS, HEART BLOCKS, AND OTHER CONDUCTION DISTURBANCES ARE COMMON IN PATIENTS WITH UNDERLYING CARDIOVASCULAR DISEASE AND/OR CONDUCTION ABNORMALITIES, AND ARE KNOWN POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY (BAV), AORTIC VALVE REPLACEMENT AND THE USE OF BIOPROSTHETIC HEART VALVES. TEMPORARY PACEMAKERS ARE INSERTED IN ALL PATIENTS UNDERGOING THE TAVR PROCEDURE TO FACILITATE RVP AND ACCURATE VALVE DEPLOYMENT. ACCORDING TO LITERATURE REVIEW AND THE (B)(6), THE CLOSE ANATOMICAL RELATIONSHIP BETWEEN THE AORTIC VALVE COMPLEX AND THE BRANCHING ATRIOVENTRICULAR BUNDLE MAY PROVIDE AN EXPLANATION FOR THESE COMPLICATIONS OF THE PROCEDURE. IT IS NOT UNCOMMON FOR PATIENTS TO HAVE SHORT TERM/REVERSIBLE PERIODS OF HEART BLOCK OR ARRHYTHMIAS FOLLOWING THE PROCEDURE. IN MANY CASES, THE TEMPORARY PM IS LEFT IN THE PATIENT FOR A SHORT TIME FOLLOWING THE PROCEDURE AND THEN SUBSEQUENTLY REMOVED PRIOR TO DISCHARGE. IN THIS CASE, THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED; HOWEVER, IN ADDITION TO PROCEDURAL FACTORS, INCLUDING VALVULOPLASTY, THE PATIENT'S UNDERLYING CARDIAC PATHOLOGY (PRE-EXISTING RBBB) COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. SINCE THERE IS NO ALLEGATION OF DEVICE MALFUNCTION, OR LABELING ISSUES, AND THE DEVICE WAS NOT RETURNED FOR PHYSICAL EVALUATION, AND NO FURTHER INVESTIGATIONAL ACTIVITIES WILL BE PERFORMED. THE IFU AND EDWARDS THV PATIENT SCREENING 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. A COMPLAINT HISTORY FOR THIS TYPE OF EVENT IS 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 VIA THE EDWARDS CLINICAL SPECIALIST, THE PATIENT EXPERIENCED ASYSTOLE FOLLOWING BALLOON AORTIC VALVULOPLASTY (BAV). THIS WAS DETECTED AFTER THE BALLOON WAS DEFLATED AND RAPID PACING WAS STOPPED. CAPTURE WAS ACHIEVED WHEN PACING WAS RESTARTED. AFTER THE VALVE WAS DEPLOYED, RAPID PACING WAS STOPPED AND IT WAS NOTICED THAT THE PATIENT WAS AGAIN IN ASYSTOLE. PACING WAS RESUMED AT A RATE OF 70BPM AND THE PATIENT REMAINED STABLE. A PERMANENT PACEMAKER (PPM) WAS LATER IMPLANTED. ACCORDING TO THE CASE SUMMARY, THE PATIENT WAS PREPPED AND DRAPED IN THE USUAL STERILE MANNER. THE RIGHT GROIN WAS USED FOR VENOUS AND ARTERIAL ACCESS. A THORACOTOMY WAS PERFORMED TO GAIN ACCESS TO THE APEX OF THE HEART. AN 18 GAUGE NEEDLE WAS USED TO ACCESS THE APEX OF THE LEFT VENTRICLE. THE WIRE AND SHEATH WAS INTRODUCED. THE EDWARDS BAV BALLOON WAS INTRODUCED AND INFLATED USING THE NORMAL DEPLOYMENT SEQUENCE. ONCE THE BALLOON WAS DOWN, PACING WAS STOPPED AND NO HEART RATE WAS SEEN. THE TEMPORARY PACER WAS TURNED ON AGAIN AT A RATE OF 70BPM. AFTER A COUPLE OF MINUTES IT WAS NOTICED THAT THE PATIENT HAD RECOVERED THEIR OWN INTRINSIC RATE. PACING WAS STOPPED AND THE VALVE WAS INTRODUCED. ONCE THE VALVE WAS POSITIONED, THE TEAM DEPLOYED THE VALVE USING THE NORMAL DEPLOYMENT SEQUENCE. WITH THE VALVE DEPLOYED, THE TEMPORARY PACER WAS TURNED OFF AND IT WAS NOTICED THAT THE PATIENT WAS IN ASYSTOLE. THE TEMPORARY PACER WAS TURNED ON AGAIN AT A RATE OF 70BPM. THE ELECTROPHYSIOLOGIST WAS CONSULTED AND A PPM WAS IMPLANTED. THE PATIENT WAS TRANSFERRED TO THE ICU IN A STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    144021 EDWARDS SAPIEN TRANSCATHETER HEART VALVE AORTIC VALVE, PROSTHESIS, PERCUTANEOUSLY DELIVERED NPT EDWARDS LIFESCIENCES 9000TFX26

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention