BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    MDR report key: 2863885 · Received December 10, 2012

    Report

    Report Number
    2015691-2012-18794
    Event Type
    Injury
    Date Received
    December 10, 2012
    Date of Event
    November 12, 2012
    Report Date
    November 12, 2012
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    LWR
    PMA / PMN Number
    P100041
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION; HOWEVER, THERE WAS NO ALLEGATION OF DEVICE MALFUNCTION. PER THE INSTRUCTIONS FOR USE, CARDIOVASCULAR INJURIES, INCLUDING PERFORATION OR DISSECTION OF VESSELS, VENTRICLE, MYOCARDIUM OR VALVULAR STRUCTURES, WHICH MAY REQUIRE INTERVENTION ARE POTENTIAL ADVERSE EVENTS ASSOCIATED WITH STANDARD CARDIAC CATHETERIZATION, BALLOON VALVULOPLASTY AND THE TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) PROCEDURE. IN THIS CASE, PER THE IMPLANTING PHYSICIAN THE PATIENT'S LVOT WAS MUSCULAR AND CREATED A SMALLER DIAMETER JUST BELOW THE ANNULUS. AS A RESULT, WHEN THE SAPIEN VALVE WAS EXPANDED IT CAUSED A LONGITUDINAL TEAR IN THE LEFT VENTRICLE WALL DIRECTLY OPPOSITE OF THE SEPTUM. ADDITIONALLY, THE PATIENT'S CARDIAC TISSUE WAS FRIABLE, WHICH WAS DESCRIBED AS HAVING ALSO CONTRIBUTED TO THE EVENT. 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 CLINICAL SPECIALIST, FOLLOWING DEPLOYMENT OF A 23MM SAPIEN VALVE VIA A TRANSAPICAL APPROACH, THE PATIENT'S BLOOD PRESSURE DID NOT IMMEDIATELY RECOVER AND BLEEDING WAS NOTED IN THE THORACOTOMY. THE LOCATION OF BLEEDING COULD NOT BE IDENTIFIED SO A FULL STERNOTOMY WAS PERFORMED TO ASSESS IF AN AORTIC RUPTURE HAD OCCURRED. THE PATIENT WAS PLACED ON FULL CARDIOPULMONARY BYPASS. A STANDARD INCISION WAS MADE FOR AORTIC VALVE REPLACEMENT IN THE AORTA AND THE SAPIEN VALVE WAS EXPLANTED. A VENTRICULAR RUPTURE WAS NOTED BELOW THE LEVEL OF THE SAPIEN VALVE. A BOVINE PERICARDIAL PATCH WAS USED TO REPAIR THE RUPTURE AND A SURGICAL AORTIC VALVE REPLACEMENT WAS PERFORMED. THE PATIENT LEFT THE OPERATING ROOM IN CRITICAL CONDITION. ON POST OP DAY ONE, THE PATIENT'S STATUS WAS NOTED TO HAVE IMPROVED. ADDITIONAL INVESTIGATION REVEALED THE FOLLOWING: THE PERCEIVED CAUSE OF THE EVENT WAS DISCUSSED WITH THE IMPLANTING PHYSICIAN. PER THE IMPLANTING PHYSICIAN, THE PATIENT'S CARDIAC TISSUE WAS FRIABLE AS "THERE WAS NO TACTILE DIFFERENCE BETWEEN PUTTING A SUTURE THROUGH THE FAT AND MUSCLE." THE PHYSICIAN STATED THAT THE LEFT VENTRICULAR OUTFLOW TRACT (LVOT) WAS SMALLER THAN HAD BEEN ASSESSED ON PRESCREENING ECHOCARDIOGRAPHY. IN ADDITION, THE LVOT WAS MUSCULAR AND CREATED A SMALLER DIAMETER JUST BELOW THE ANNULUS, SO WHEN THE SAPIEN VALVE WAS EXPANDED IT CAUSED A LONGITUDINAL TEAR IN THE VENTRICLE WALL DIRECTLY OPPOSITE OF THE SEPTUM. THERE WAS NO ANNULAR RUPTURE OR EXCESSIVE BLEEDING FROM THE TRANSAPICAL ACCESS SITE. ON POST OPERATIVE DAY EIGHT THE PATIENT WAS NOTED TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS SAPIEN TRANSCATHETER HEART VALVE TRANSCATHETER HEART VALVE LWR EDWARDS LIFESCIENCES 9000TFX23

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention