BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN PALMAZ STENT

    MDR report key: 7283796 · Received February 20, 2018

    Report

    Report Number
    9616099-2018-01903
    Event Type
    Injury
    Date Received
    February 20, 2018
    Date of Event
    January 26, 2018
    Report Date
    March 22, 2018
    Manufacturer
    CORDIS CASHEL
    Product Code
    FGE
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED. AS NOTED IN A LITERATURE 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. POPLITEAL ARTERY THROMBOSIS OCCURRED IN ONE PATIENT SECONDARY TO PROBABLE INTRAPROCEDURAL THROMBOEMBOLISM. THIS WAS IMMEDIATELY CORRECTED WITH THROMBECTOMY AND PATCH GRAFTING. THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL, WAS 20 CM IN LENGTH AND THE GRAFT WAS 35 CM. 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 ¿THROMBOSIS¿ 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 1

    AS NOTED IN A LITERATURE 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. POPLITEAL ARTERY THROMBOSIS OCCURRED IN ONE PATIENT SECONDARY TO PROBABLE INTRAPROCEDURAL THROMBOEMBOLISM. THIS WAS IMMEDIATELY CORRECTED WITH THROMBECTOMY AND PATCH GRAFTING. THE LESION WAS LOCATED IN THE SUPERFICIAL FEMORAL, WAS 20 CM IN LENGTH AND THE GRAFT WAS 35 CM. THE DEVICE REQUIRED A 14-F INTRODUCER SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127710 UNKNOWN PALMAZ STENT CATHETER, BILIARY, DIAGNOSTIC FGE CORDIS CASHEL UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| S