BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PALMAZ STENT

    MDR report key: 7290633 · Received February 22, 2018

    Report

    Report Number
    9616099-2018-01924
    Event Type
    Injury
    Date Received
    February 22, 2018
    Date of Event
    January 26, 2018
    Report Date
    February 22, 2018
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT WAS IDENTIFIED DURING A RECENT CLINICAL EVALUATION REVIEW/LITERATURE SEARCH OF THIS DEVICE. THE DEVICE IS A PALMAZ STENT BUT THE EXACT CATALOG AND LOT NUMBERS ARE NOT AVAILABLE. THE CITATION IS AS FOLLOWS: UNDQUIST ET AL ENDOVASCULAR TREATMENT OF ATHEROSCLEROTIC LOWER LIMB LESIONS USING A PTFE-COLLARED STENT-GRAFT; J ENDOVASC THER 2000;7:221¿226. AS NOTED IN THE PUBLICATION LUNDQUIST ET AL ENDOVASCULAR TREATMENT OF ATHEROSCLEROTIC LOWER LIMB LESIONS USING A PTFE-COLLARED STENT-GRAFT; J ENDOVASC THER 2000;7:221¿226; DESIGNED AN ENDOGRAFT USING A 3-MM-DIAMETER BALLOON-EXPANDABLE PTFE GRAFT WITH TERMINAL PALMAZ STENTS PLACED ON THE OUTSIDE OF THE GRAFT, FOLDING THE PTFE BACK OVER THE STENTS TO FORM A COLLAR AT EACH END. DURING THE PROCEDURE THERE WAS VESSEL INJURY. DURING THE 3 MONTH FOLLOW UP THERE WAS ALSO OCCLUSION OF THE GRAFT. THE LESION WAS LOCATED IN THE COMMON ILIAC ARTERY, IT WAS 12CM IN LENGTH AND THE GRAFT WAS 15CM. THE DEVICE REQUIRED A 14-F INTRODUCER SYSTEM. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS. NO LOT NUMBER WAS PROVIDED THEREFORE A PRODUCT HISTORY RECORD (PHR) REVIEW COULD NOT BE GENERATED. THE REPORTED ¿VASCULAR GRAFT OCCLUSION¿ AND ¿INJURY TO ILIAC VESSEL(S), UNSPECIFIED¿ COULD NOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR ANALYSIS. THE EXACT CAUSE COULD NOT BE DETERMINED. VESSEL CHARACTERISTICS ARE UNKNOWN; HOWEVER THE DISEASE WAS NOTED TO BE CHRONIC, PERFUSE AND FLOW-LIMITING, AND HIGHLY SYMPTOMATIC. THE DEVICE WAS CREATED DURING THE PROCEDURE AD HOC, AND THE METHOD OF INSERTING THE DEVICES CAUSED SEVERAL INSTANCES OF TRAUMA, DISTAL EMBOLIZATION AND INACCURATE POST-DILATION. THIS RESULTED IN THE STATED VESSEL INJURY AND SUBSEQUENT OCCLUSION OF THE GRAFT. THIS WAS EXPERIMENTAL AND OFF-LABEL USAGE OF THE DEVICE AND THE INSTRUCTIONS FOR USE WERE NOT FOLLOWED. AS NO LOT NUMBER, CATALOGUE CODE OR OTHER PRODUCT INFORMATION WAS SUPPLIED A PHR COULD NOT BE COMPLETED. ACCORDING TO THE INTENDED USE IN THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿THE CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM IS INTENDED FOR USE IN THE PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE.¿ THE LIMITED INFORMATION AVAILABLE DOES NOT SUGGEST A DESIGN OR MANUFACTURING RELATED CAUSE FOR THE REPORTED EVENT; THEREFORE, NO CORRECTIVE/PREVENTIVE ACTION WILL BE TAKEN AT THIS TIME. THIS IS ONE OF TWO REPORTS ASSOCIATED WITH THIS EVENT AND THE ASSOCIATED MANUFACTURING REPORT NUMBER IS 9616099-2018-01923.

    Description of Event or Problem · 1

    AS NOTED IN THE PUBLICATION LUNDQUIST ET AL ENDOVASCULAR TREATMENT OF ATHEROSCLEROTIC LOWER LIMB LESIONS USING A PTFE-COLLARED STENT-GRAFT; J ENDOVASC THER 2000;7:221¿226; DESIGNED AN ENDOGRAFT USING A 3-MM-DIAMETER BALLOON-EXPANDABLE PTFE GRAFT WITH TERMINAL PALMAZ STENTS PLACED ON THE OUTSIDE OF THE GRAFT, FOLDING THE PTFE BACK OVER THE STENTS TO FORM A COLLAR AT EACH END. DURING THE PROCEDURE THERE WAS VESSEL INJURY. DURING THE 3 MONTH FOLLOW UP THERE WAS ALSO OCCLUSION OF THE GRAFT. THE LESION WAS LOCATED IN THE COMMON ILIAC ARTERY, T WAS 12CM IN LENGTH AND THE GRAFT WAS 15CM. THE DEVICE REQUIRED A 14-F INTRODUCER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132218 UNKNOWN PALMAZ STENT ENDOVASCULAR STENT DELIVERY SYSTEM FGE CORDIS CORPORATION N/A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L