BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS

    MDR report key: 3023880 · Received March 27, 2013

    Report

    Report Number
    2015691-2013-19672
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Date of Event
    July 6, 2012
    Report Date
    February 27, 2013
    Manufacturer
    EDWARDS LIFESCIENCES
    Product Code
    DYE
    PMA / PMN Number
    P860057/S022
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO DEVICE RETURN. THE DHR REVIEW WAS COMPLETED. THIS DEVICE PASSED ALL MANUFACTURING AND STERILIZATION INSPECTIONS WITH NO NONCONFORMANCE. THE PATIENT COMPLAINED OF SHORTNESS OF BREATH ON EXERTION AND WAS DIAGNOSED WITH PARAVALVULAR LEAK APPROXIMATELY 4 MONTHS AFTER IMPLANT OF THE AORTIC VALVE. HE WAS PRESCRIBED A DIURETIC BUT FELT IT DID NOT IMPROVE HIS SYMPTOMS AND THE DOCTOR REDUCED HIS DOSAGE FROM 40MG TO 20MG DAILY. A PARAVALVULAR LEAK IS DESCRIBED AS A LEAK OUTSIDE THE VALVE, NOT GOING THROUGH THE LEAFLETS, AND REPRESENTS REGURGITANT FLOW BETWEEN THE SEWING RING AND THE AORTIC WALL. IF HEMODYNAMICALLY SIGNIFICANT, THIS WILL REQUIRE REPLACEMENT OF THE HEART VALVE. THERE ARE SEVERAL CONTRIBUTING FACTORS TO A PARAVALVULAR LEAK, INCLUDING BUT NOT LIMITED TO, INSUFFICIENT DEBRIDEMENT OF CALCIFIED TISSUE, SURGICAL TECHNIQUE, AND PATIENT FACTORS (FRAGILE TISSUE). IN THIS CASE, THE HEALTH CARE PROVIDER STATED "THE AREA MOST LIKELY WAS HEAVILY CALCIFIED AND DID NOT SEAL". THE DEVICE WILL NOT BE RETURNED FOR EVALUATION BECAUSE IT REMAINS IMPLANTED AND THERE ARE NO PLANS TO EXPLANT THIS DEVICE. THEREFORE, THERE IS INSUFFICIENT INFORMATION TO CONCLUSIVELY DETERMINE THE ROOT CAUSE FOR THE REPORTED PARAVALVULAR LEAK.

    Description of Event or Problem · 1

    REPORTEDLY, THE PATIENT COMPLAINED OF SOME DYSPNEA ON EXERTION AND SLIGHT EDEMA OF HIS RIGHT LOWER EXTREMITY. THE PATIENT, WHO IS AN (B)(6), WAS DIAGNOSED WITH A PARAVALVULAR LEAK, 3 MONTHS AND 30 DAYS POST IMPLANTATION OF A 21MM BIOPROSTHETIC VALVE. CLINICAL NOTES INDICATE THE AREA MOST LIKELY WAS HEAVILY CALCIFIED AND DID NOT SEAL. CHEST X-RAY WAS CLEAR AND A 2-DIMENSIONAL ECHOCARDIOGRAM SUGGESTED PERIPROSTHETIC LEAK. FURTHER TEE SHOWED A SEMILUNAR OPENING WITH SIGNIFICANT PERIPROSTHETIC VALVE INSUFFICIENCY. FUROSEMIDE WAS PRESCRIBED WITH LITTLE RELIEF FROM SYMPTOMS OF EDEMA. NO ACTION WAS TAKEN AS THE PATIENT DOES NOT WANT TO RE-DO HEART SURGERY. THERE ARE NO PLANS TO REPLACE THE VALVE. PATIENT STATUS IS UNCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125652 CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS HEART-VALVE, REPLACEMENT DYE EDWARDS LIFESCIENCES 3000TFX S-11K3626

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR FUROSEMIDE, 20MG, DAILY