BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS 39MM BILIARY

    MDR report key: 3112688 · Received May 14, 2013

    Report

    Report Number
    1016427-2013-00060
    Event Type
    Injury
    Date Received
    May 14, 2013
    Date of Event
    September 26, 2005
    Report Date
    April 19, 2013
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K020809
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THIS EVENT WAS FOUND IN A LITERATURE REVIEW. THE CITATION IS AS FOLLOWS: CHESSA ET AL RESULTS AND MID-LONG - TERM FOLLOW-UP OF STENT IMPLANTATION FOR NATIVE AND RECURRENT COARCTATION OF THE AORTA; EUROPEAN HEART JOURNAL (2005) 26, 2778-2732. CHESSA ET AL RESULTS AND MID-LONG - TERM FOLLOW-UP OF STENT IMPLANTATION FOR NATIVE AND RECURRENT COARCTATION OF THE AORTA; EUROPEAN HEART JOURNAL (2005) 26, 2778-2732, REPORT A CASE IN WHICH A CASE OF RE-DILATATION WAS PERFORMED 21 MONTHS AFTER STENT IMPLANTATION OF A PALMAZ STENT. THIS PATIENT HAD TWO PREVIOUS SURGICAL OPERATIONS (END-TO-END ANASTOMOSIS AND, THEN, A SUBCLAVIAN ARTERY FLAP). THE PATIENT UNDERWENT SUCCESSFUL STENT IMPLANTATION (PALMAZ 5014 STENT WITH BALT 12 MMX50 MM BALLOON CATHETER), BUT AFTER 21 MONTHS, A PRESSURE GRADIENT OF 33 MMHG WAS RECORDED AT CATHETERIZATION AND THE STENT WAS RE-DILATED WITH A 15 MM/50 MM BALLOON CATHETER, THE GRADIENT DROPPED TO 7 MMHG. A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED AS THE STERILE LOT NUMBER WAS NOT AVAILABLE. RESTENOSIS IS A KNOWN POTENTIAL ADVERSE EVENT ASSOCIATED WITH IMPLANTING STENTS AND IS OFTEN ASSOCIATED WITH THE PROGRESSION OF PERIPHERAL ARTERIAL DISEASE. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN. AN ANEURYSM MAY BE CAUSED BY MULTIPLE FACTORS THAT RESULT IN THE BREAKING DOWN OF THE WELL-ORGANIZED STRUCTURAL COMPONENTS (PROTEINS) OF THE AORTIC WALL THAT PROVIDE SUPPORT AND STABILIZE THE WALL. THE EXACT CAUSE IS NOT FULLY KNOWN. ATHEROSCLEROSIS (HARDENING OF THE ARTERIES) IS THOUGHT TO PLAY AN IMPORTANT ROLE IN ANEURYSMAL DISEASE. BASED ON THE AVAILABLE INFORMATION THERE IS NO EVIDENCE TO SUGGEST THAT THE EVENT WAS DESIGN OR MANUFACTURING RELATED THEREFORE NO CORRECTIVE ACTION WILL BE TAKEN.

    Description of Event or Problem · 1

    CHESSA ET AL RESULTS AND MID-LONG - TERM FOLLOW-UP OF STENT IMPLANTATION FOR NATIVE AND RECURRENT COARCTATION OF THE AORTA; EUROPEAN HEART JOURNAL (2005) 26, 2778-2732, REPORT A CASE IN WHICH 1 YEAR AFTER THE IMPLANTATION OF A PALMAZ-GENESIS 3910 STENT DILATED UP TO 12 MM, (A (B)(6) WOMAN) WAS RECATHETERIZED FOLLOWING DOPPLER EVIDENCE OF A RESIDUAL SIGNIFICANT GRADIENT AND ANEURYSM FORMATION AT THE PROXIMAL END OF THE STENT PER ANGIOGRAPHY. RE-DILATION OF THE STENT AND IMPLANTATION OF A COVERED CP STENT EIGHT ZIG 39 MM WERE CARRIED OUT SUCCESSFULLY. ANGIOGRAPHY CONFIRMED RE-COARCTATION (PEAK GRADIENT OF 24 MMHG).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213020 PALMAZ GENESIS 39MM BILIARY ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 27 YR Hospitalization| L| R