BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPLACEMENT HEART VALVE

    MDR report key: 1996872 · Received February 19, 2011

    Report

    Report Number
    2015691-2011-14843
    Event Type
    Injury
    Date Received
    February 19, 2011
    Date of Event
    July 2, 2010
    Report Date
    January 21, 2011
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED AND THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE.

    Additional Manufacturer Narrative · 1

    PER THE OPERATIVE REPORT: "PROCESS OF OPERATION: VERY DIFFICULT. NORMAL PRE-SURGICAL PROCEDURE (COVERING PT., DISINFECTION). CLASSIC FULL STERNOTOMY, HEMOSTASIS AND PLACING OF THE SPREADER. PLACING OF THE STITCHES: ON PERICARD (TIRONE DAVID'S METHOD) CANULATION OF AORTA AND VENA CAVA INFERIOR AND SUPERIOR AND START OF EXTRACORPOREAL CIRCULATION. COOLING TILL 32 DEGREES CELSIUS AND CANULATION OF LEFT CHAMBER WITH VENTING CATHETER. PLACING OF CROSS-CLAMP AND ADMINISTRATION OF ANTEROGRADE COLD CRYSTALLOID CARDIOPLEGIA 2000 ML. CARDIAC ARREST AFTER 600 ML. (SEE REPORT FOR S/N (B)(4) FOR AVR AND RE-AVR). OPENING OF THE LEFT ATRIUM. FREEING SONDERGAARDS GROOVE. FINDINGS: MITRAL VALE SEVERELY CALCIFIED, LEAFLETS AS WELL AS ANNULUS. LABORIOUS DECALCIFICATION AND EXTENDED RINSING. RESECTION OF THE VALVE AND PLACING MAGNA MITRAL 31 MM BIO VALVE, STITCHED WITH INTERMITTED STITCHES 2/0 WITH TEFLON. AFTER LEAKAGE CHECK, CLOSING OF THE ATRIA WITH PROLENE 3/0. DUE TO A CENTRAL LEAK THE VALVE IS REPLACED BY A MAGNA MITRAL 29 MM AFTER NEXT DOSIS CARDIOPLEGIA. CAREFUL DEFLATING OF LEFT VENTRICLE AFTER FILLING AND START RESPIRATION PLACING OF 2 ATRIAL AND TWO VENTRICULAR PACEMAKER LEADS AND 1 STRAIGHT AND 2 CURVED THORAX DRAINS. CLASSIC WEANING OF EXTRACORPOREAL CIRCULATION WITH INOTROPICA." AT THE CONCLUSION OF THE SURGERY, THERE WAS NO MENTION OF ANY ISSUE WITH THE REPLACEMENT DEVICE. THE SURGEON'S RESPONSE INDICATED THAT THIS DEVICE WAS EXPLANTED DUE TO A SIZING ISSUE (IMPLANTED A SMALLER DEVICE) AND NOT DUE TO A MALFUNCTION OF THE DEVICE. DUE TO THE DIFFICULTY AND LENGTH OF SURGERY, THIS IS BEING REPORTED. THE HEALTH CARE PROVIDER DOES NOT KNOW IF THE DEVICE WAS SAVED. THEREFORE, IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR RETURN. THE CAUSE OF DEATH WAS NOT PROVIDED. CLOSING OPERATIVE REPORT "POSTOPERATIVE" NOTATION "STAY ON CARDIOSURGERY: YOUR PATIENT DIED ON INTENSIVE CARE ON (B)(6) 2010, BEFORE SHE WAS DISMISSED TO THE CARDIOSURGERY DEPT." TEE POSTOP: MILD LEFT AND RIGHT VENTRICLE FUNCTION. NO AI - MI. NO ECHO PROVIDED; NO DISCHARGE SUMMARY PROVIDED; NO AUTOPSY NOTED.

    Additional Manufacturer Narrative · 1

    THIS MODEL IS DISTRIBUTED OUTSIDE OF THE UNITED STATES AND IS BEING REPORTED AS SIMILAR TO MODEL 2800, WHICH IS MARKETED WITHIN THE UNITED STATES. METHOD: DEVICE NOT RETURNED. ADDITIONAL MANUFACTURER NARRATIVE: ACCORDING TO THE IMPLANTATION DATA CARDS RETURNED BY THE HOSPITAL, THERE WERE FOUR DEVICES USED ON THIS PATIENT ON (B)(6) 2010. IT IS NOT KNOWN IF THE EXPLANTS AND IMPLANTS WERE PERFORMED WITHIN THE SAME OPERATION. TWO DEVICES WERE EXPLANTED AT IMPLANT (REPORTED UNDER S/N (B)(4) AND S/N (B)(4)) AND REPLACED ON THE SAME DATE OF SURGERY (REPORTED UNDER S/N (B)(4) AND S/N (B)(4)). THERE WAS A NOTATION ON THE CARDS FOR THOSE DEVICES THAT REMAIN IMPLANTED THAT THE PATIENT HAS EXPIRED. EACH EXPLANTED DEVICE WAS REPLACED BY A SMALLER SIZE OF THE SAME MODEL DEVICE. THE DATE AND CAUSE OF DEATH WERE NOT PROVIDED. AVAILABILITY OF DEVICE RETURN WAS NOT PROVIDED. THERE HAS BEEN NO CONFIRMATION OF THE PATIENT'S DEATH. THERE HAS BEEN NO PATIENT HISTORY PROVIDED. NO OPERATIVE REPORT OR DISCHARGE SUMMARY PROVIDED. NO AUTOPSY HAS BEEN PROVIDED. IT IS UNKNOWN IF THERE IS ANY EDWARDS DEVICE INVOLVEMENT IN THE DEATH OF THIS PATIENT. THE DEVICE HISTORY RECORD REVIEW IS IN PROCESS DESPITE OUR ATTEMPTS TO RECEIVE FURTHER INFORMATION REGARDING THESE DEVICES AND EVENT, NO RESPONSE OR SAMPLE FOR EVALUATION HAS BEEN RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2011, IT WAS LEARNED THAT THE PATIENT'S DEATH WAS NOT RELATED TO THE DEVICE. THE OPERATIVE REPORT WAS INITIALLY NOT PROVIDED IN ENGLISH BUT HAS SINCE BEEN TRANSLATED.

    Description of Event or Problem · 1

    EDWARDS LIFESCIENCES MAINTAINS AN IMPLANT PATIENT REGISTRY. THIS REGISTRY IS A PATIENT TRACKING MECHANISM FOR SERIALIZED EDWARDS IMPLANTABLE DEVICES (BIOPROSTHETIC HEART VALVES AND ANNULOPLASTY RINGS), RATHER THAN A TRUE POST-MARKET SURVEILLANCE REGISTRY. THROUGH THE REGISTRY, EDWARDS IS NOTIFIED WHEN THESE DEVICES ARE IMPLANTED. IN ADDITION, PATIENT AND/OR DEVICE STATUS MAY BE REPORTED TO THE REGISTRY VIA THE IMPLANTATION DATA CARDS. THE INFORMATION IS RECEIVED FROM VARIOUS SOURCES (E.G. SURGEON, HOSPITAL, AND PATIENT FAMILY MEMBERS) AND IS NOT RECEIVED IN THE FORM OF A CONVENTIONAL "CUSTOMER COMPLAINT". THE INFORMATION REPORTED MAY OR MAY NOT BE RELATED TO THE EDWARDS DEVICE. IN THIS CASE, THE DEVICE WAS EXPLANTED AT IMPLANT AND REPLACED BY A SMALLER SIZE OF THE SAME MODEL DEVICE FOR UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPLACEMENT HEART VALVE DYE EDWARDS LIFESCIENCES SEE H10 10D085

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Death| H| R