BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ BLUE BILIARY ON SLALOM

    MDR report key: 20217774 · Received September 13, 2024

    Report

    Report Number
    3007635982-2024-00227
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    July 29, 2024
    Report Date
    September 13, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    FGE
    UDI-DI
    10705032036313
    PMA / PMN Number
    K040413
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE 6X24 PALMAZ BLUE ON SLALOM BALLOON EXPANDABLE STENT WAS NOTED TO HAVE FRACTURED AND SEPARATED IN THE CELIAC ARTERY AFTER BEING PLACED APPROXIMATELY FIFTEEN MONTHS AGO. APPROXIMATELY FIFTEEN MONTHS AFTER INITIAL PLACEMENT, THE PATIENT HAD A NON-CORDIS 6X29 COVERED STENT PLACED. THE NON-CORDIS STENT WAS PLACED TO COVER AND RE-STABILIZE THE FRACTURED PALMAZ STENT. THIS WAS AN INCIDENTAL FINDING AS THE PATIENT WAS FOLLOWING UP FOR MESENTERIC ISCHEMIA. THE PATIENT PRESENTED A RE-STENOSIS OF GREATER THAN 70% OF THE PALMAZ BLUE STENT. BASED ON THE LIMITED INFORMATION PROVIDED, IT IS NOT POSSIBLE TO DRAW A CONCLUSION ABOUT A CLINICAL RELATIONSHIP BETWEEN THE DEVICE AND THE EVENT. WITHOUT THE RETURN OF THE DEVICE FOR ANALYSIS, THE REPORTED CUSTOMER COMPLAINT " STENT FRACTURED-SEPARATED" COULD NOT BE CONFIRMED. ACCORDING TO THE INDICATIONS FOR USE IN THE SAFETY INFORMATION IN THE INSTRUCTIONS FOR USE ¿THE PALMAZ GENESIS TRANSHEPATIC BILIARY STENT IS INDICATED FOR PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE. THE SAFETY AND EFFECTIVENESS OF THIS DEVICE FOR USE IN THE VASCULAR SYSTEM HAVE NOT BEEN ESTABLISHED.¿ THIS EVENT IS CONSIDERED A VIOLATION OF THE IFU AND AS SUCH, OFF LABEL USAGE. TO AVOID THE POSSIBILITY OF DISSIMILAR METAL CORROSION. DO NOT IMPLANT STENTS OF DIFFERENT METALS IN TANDEM WHERE OVERLAP OR CONTACT IS POSSIBLE, WITH AN EXCEPTION, STENTS MADE OF 316L STAINLESS STEEL ARE COMPATIBLE WITH STENTS OF NICKEL TITANIUM ALLOY. NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, THE 6X24 PALMAZ BLUE ON SLALOM BALLOON EXPANDABLE STENT WAS NOTED TO HAVE FRACTURED AND SEPARATED IN THE CELIAC ARTERY AFTER BEING PLACED APPROXIMATELY FIFTEEN MONTHS AGO. APPROXIMATELY FIFTEEN MONTHS AFTER INITIAL PLACEMENT, THE PATIENT HAD A NON-CORDIS 6X29 COVERED STENT PLACED. THE NON-CORDIS STENT WAS PLACED TO COVER AND RE-STABILIZE THE FRACTURED PALMAZ STENT. THIS WAS AN INCIDENTAL FINDING AS THE PATIENT WAS FOLLOWING UP FOR MESENTERIC ISCHEMIA. THE PATIENT PRESENTED A RE-STENOSIS OF GREATER THAN 70% OF THE PALMAZ BLUE STENT. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. ADDENDUM: ONE IMAGE WAS PROVIDED FOR REVIEW, A STENT IS VISIBLE, AND A FRACTURED/SEPARATED CONDITION OF THE STENT IS OBSERVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1564688 PALMAZ BLUE BILIARY ON SLALOM STENTS, DRAINS AND DILATORS FOR THE BILIARY DUCTS FGE CORDIS US. CORP 82234528 10705032036313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening| O 6X29 VIABAHN VBX COVERED STENT