BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDWARDS PERICARDIAL PATCH

    MDR report key: 1771113 · Received July 27, 2010

    Report

    Report Number
    2015691-2010-13766
    Event Type
    Injury
    Date Received
    July 27, 2010
    Report Date
    June 23, 2010
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DXZ
    PMA / PMN Number
    K082139
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4) = POST MYOCARDIAL INFARCTION VENTRICULAR SEPTAL DEFECT.DEVICE NOT RETURNED. THE EVENT WAS LEARNED THROUGH EDWARDS LIFESCIENCES IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM RATHER THAN A CLINICAL STUDY. THERE IS NO ALLEGATION OF A PRODUCT MALFUNCTION. THIS WAS A VERY ILL PATIENT WHO SUBSEQUENTLY WAS TRANSFERRED FOR IMPLANTATION OF LVAD (LEFT VENTRICULAR ASSIST DEVICE). IT CANNOT BE CONFIRMED AT THIS TIME, HOWEVER IT IS LIKELY THAT THE PATCHES WERE EXPLANTED AT THE TIME THE LVAD WAS INSERTED. THE PATIENT ALSO HAD ANOTHER PATCH EXPLANTED, (B) (4). THE DEVICE HISTORY RECORD (DHR) REVIEW IS CURRENTLY IN PROCESS.

    Additional Manufacturer Narrative · 1

    THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, IT HAS BEEN CONFIRMED THAT THE PATCH WAS EXPLANTED AT THE TIME THE LVAD WAS INSERTED ((B)(6)2010). PER THE OPERATIVE REPORT OF (B)(6)2010, "...IT WAS OBVIOUS THAT THE PATCH REPAIR AND THE SEPTAL HEMATOMA HAD MARKEDLY DISTORTED THE TRICUSPID VALVE RENDERING IT COMPLETELY INCOMPETENT, SO THE TRICUSPID VALVE WOULD NEED TO BE REPLACED. ON INSPECTION, THE MITRAL VALVE HAD A NUMBER OF TORN CHORDAE TO THE ANTERIOR LEAFLET AND IT WAS NOT CLEAR WHAT WAS THE GENESIS OF THIS UNLESS IT WAS RELATED TO THE IMPELLER PUMP. THERE ENTIRE POSTERIOR AND POSTEROLATERAL WALL WERE INFARCTED. THE ANTEROLATERAL PAPILLARY MUSCLE WAS COMPLETELY INFARCTED AS WAS THE POSTEROMEDIAL PAPILLARY MUSCLE. THERE WAS AN EXTENSIVE INFARCTION OF THE ATRIAL SEPTUM." THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED, AND THERE WAS NO NONCONFORMANCE FOUND RELATED TO THIS EVENT.

    Description of Event or Problem · 1

    IT WAS INITIALLY REPORTED (BY THE PATIENT'S WIFE), THAT THE PATCH (IMPLANTED ON (B) (6)2010) HAS BEEN EXPLANTED. THROUGH FOLLOW-UP WITH THE HEALTH-CARE PROVIDER, THE FOLLOWING WAS LEARNED. THE PATIENT WAS ADMITTED WITH POST MYOCARDIAL INFARCTION VENTRICULAR SEPTAL DEFECT. ON (B) (6)2010, THE PATIENT UNDERWENT THE FOLLOWING SURGICAL PROCEDURE: REPAIR OF RUPTURED VENTRICULAR SEPTAL DEFECT; AORTOCORONARY BYPASS GRAFT SURGERY X2 - BYPASSES CONSISTING OF LEFT INTERNAL MAMMARY ARTERY TO THE LAD, BYPASS CONSISTING OF SAPHENOUS GRAFT FROM AORTA TO THE DIAGONAL. FOLLOWING BYPASS, AN OPENING ALONG THE RIGHT VENTRICULAR SIDE OF THE SEPTUM WAS MADE TO DEMONSTRATE THE VSD. THE LEFT SIDE OF THE SEPTUM IN THE LEFT VENTRICLE WAS OPENED, AND A PROBE WAS PASSED THROUGH THIS VSD. THIS VSD WAS LARGER THAN ANTICIPATED AND ESTIMATED TO BE ABOUT A QUARTER IN DIAMETER. A DOUBLE PATCH OF BOVINE PERICARDIUM WAS SECURED IN A GENEROUS AREA OF THE HEALTHY SEPTUM. THE PATIENT WAS WEANED OFF CARDIOPULMONARY BYPASS WITHOUT DIFFICULTIES. ON EXAMINATION ON THE MORNING OF (B) (6), AN APICAL MURMUR WAS HEARD. OVER THE COURSE OF THE AFTERNOON AND EVENING, THE PATIENT BECAME MOTTLED AND MORE DRUGS WERE INSTITUTED. THE PATIENT WAS AUGMENTED AT ONE TO ONE. AT ABOUT 10 O'CLOCK, THE PATIENT WAS COOL, BLOOD PRESSURE 90-100, HEART RATE WAS ABOUT 130. CONCERNED THAT THE PATIENT WAS IN A LOW OUTPUT STATE BECAUSE OF DECREASED COMPLIANCE IN HIS MYOCARDIUM AND HIS IMPAIRED STROKE VOLUME, A CALL WAS MADE TO (B) (6) CLINIC, HEART FAILURE/SURGICAL DEPARTMENT, WHO WERE WILLING TO ACCEPT THE PATIENT TRANSFER. THEY REQUESTED THE PATIENT TO BE PUT ON ECMO. AN ECMO CIRCUIT WAS INSERTED, AND THE PATIENT WAS TRANSFERRED TO THE FACILITY FOR VENTRICULAR ASSIST DEVICE MANAGEMENT. THE PATIENT'S STATUS AND DATE OF PATCH EXPLANT ARE UNKNOWN TO EDWARDS LIFESCIENCES AT THIS TIME. HOWEVER, IT WAS LEARNED THAT THE PATIENT RECENTLY UNDERWENT A HEART TRANSPLANT ON (B) (6)2010 AND A CHEST EXPLORATION ON (B) (6)2010. ADDITIONAL INFORMATION IN ANTICIPATED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN ISSUE WITH THEIR METER WHICH SUGGESTS THE MEMORY OVERWRITE MALFUNCTION HAS OCCURRED. THERE WAS NO REPORT OF DEATH OR SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EDWARDS PERICARDIAL PATCH PERICARDIAL PATCH DXZ EDWARDS LIFESCIENCES 4700 R-09L2637

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR