BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDIOCEL

    MDR report key: 4611543 · Received March 13, 2015

    Report

    Report Number
    3010805634-2015-00006
    Event Type
    Injury
    Date Received
    March 13, 2015
    Date of Event
    February 6, 2015
    Report Date
    March 13, 2015
    Manufacturer
    ADMEDUS REGEN PTY LTD
    Product Code
    DXZ
    PMA / PMN Number
    K130872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS BEING CONSERVATIVELY REPORTED AS STENOSIS OF PULMONARY ARTERIES REQUIRING SURGICAL RE-INTERVENTION IS AN EXPECTED EVENT IN APPROXIMATELY 12-15% OF CONGENITAL CARDIAC PATIENTS ACCORDING TO PEER REVIEWED LITERATURE. DUE TO LACK OF INFORMATION, THIS CASE IS NOT CURRENTLY ASSESSABLE. ADMEDUS IS IN THE PROCESS OF FOLLOWING-UP WITH THE REPORTER FOR ADDITIONAL INFORMATION. ADMEDUS HAS ALSO REQUESTED HISTOLOGICAL EVALUATION OF THE EXPLANT MATERIAL. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE ADDITIONAL INFORMATION BECOMES AVAILABLE AND IS EVALUATED.

    Description of Event or Problem · 1

    ADMEDUS RECEIVED THE FOLLOWING INFORMATION FROM A FOREIGN FACILITY - TREATMENT SUMMARY: AT (B)(6) OF LIFE: MODIFIED NORWOOD OPERATION ( DKS, ATRIAL SEPTECTOMY, PARTIALLY SNARED 6MM GORETEX RIGHT VENTRICULAR-PULMONARY ARTERY CONDUIT ) WITH RV-PA CONDUIT BANDED TO DECREASE THE PULMONARY BLOOD FLOW. CARDIOCEL WAS USED FOR ANTERIOR PATCHING OF AORTIC ARCH AND PATCHING OF TRANSECTED MAIN PULMONARY ARTERY (TO WHICH THE PULMONARY END OF RIGHT VENTRICULAR-PULMONARY ARTERY CONDUIT WAS ANASTOMOSED). AT 4 MONTHS POSTOPERATIVELY, A CARDIAC CATHETERISATION WAS PERFORMED (SNARE ON RV-PA CONDUIT SUCCESSFULLY BALLOON DILATE). STENOSIS AT DISTAL RIGHT VENTRICULAR-PULMONARY ARTERY CONDUIT AND CARDIOCEL ANASTOMOSIS OBSERVED. NO IMPROVEMENT IN OXYGEN SATURATIONS POST PROCEDURE. TAKE DOWN OF NORWOOD TO BVR (PULMONARY ARTERY RECONSTRUCTION WITH HOMOGRAFT PATCHES). CARDIOCEL PATCH USED TO PATCH MPA WAS OBSERVED TO HAVE THICKENED AT THE ANASTOMOSIS END OF THE GORTEX RIGHT VENTRICULAT-PULMONARY ARTERY WITH A THICK NEO-INTIMAL LAYER EXTENDING INTO THE OBSTRUCTING BOTH BRANCH WITH STENOSIS OF THE DISTAL RX-PA CONDUIT TO PATCH ANASTOMOSIS. NO AORTIC ARCH NEGATIVE OBSERVATIONS WHERE CARDIOCEL WAS USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173834 CARDIOCEL CARDIAC PATCH DXZ ADMEDUS REGEN PTY LTD C0404 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Congenital Anomaly| R