BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ XL STENT PER 50MM OUS

    MDR report key: 3112586 · Received May 14, 2013

    Report

    Report Number
    1016427-2013-00059
    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
    K993091
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS ARTICLE WAS FOUND DURING A RECENT CLINICAL EVALUATION REVIEW OF THIS DEVICE. 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. A DEVICE HISTORY RECORD REVIEW WAS NOT PERFORMED AS THE STERILE LOT NUMBER IS 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.

    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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    213319 PALMAZ XL STENT PER 50MM OUS ENDOVASCULAR SDS/STENTS FGE CORDIS CORPORATION NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R