BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PALMAZ XL STENT PER 50MM OUS

    MDR report key: 2915523 · Received January 15, 2013

    Report

    Report Number
    1016427-2013-00006
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 19, 2012
    Report Date
    December 20, 2012
    Manufacturer
    CORDIS CORPORATION
    Product Code
    FGE
    PMA / PMN Number
    K993091
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT HAS BEEN RETURNED FOR EVALUATION AND TESTING; HOWEVER, THE ENGINEERING EVALUATION HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    COMPLAINT CONCLUSION: DURING AN AAA GRAFT STENTING CASE, A LITTLE LEAK WAS FOUND. THE PHYSICIAN MOUNTED A 50MM X-LARGE PALMAZ UNMOUNTED STENT ON A BALLOON; HOWEVER THE STENT WAS LOOSE AND IT WAS DECIDED NOT TO USE THE DEVICE. AN ADDITIONAL STENT GRAFT WAS DEPLOYED OVERLAPPING THE PREVIOUS GRAFT (NON-CORDIS). THE SDS WAS PREPPED ACCORDING TO IFU GUIDELINES, THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE AND THE DIFFICULTY OCCURRED WHILE THE DEVICES WERE BEING PRELOADED OUTSIDE OF THE PATIENT. THE ANALYSIS REVEALED THAT THE STENT WAS SLIGHTLY BENT ON ONE END AND SEVERELY DAMAGED ON THE OTHER. IT APPEARS THAT IT HAD NOT BEEN USED PROPERLY AS STATED ABOVE. A DOCUMENT HISTORY REVIEW OF THE BATCH RECORDS IN QUESTION (B)(4) LOT NUMBER N0809306. THERE WERE NO ANOMALIES FOUND AND THE PRODUCT WAS MANUFACTURED, PACKAGED AND LABELED TO ALL CORDIS SPECIFICATIONS. THE COMPLAINT REPORTED BY THE CUSTOMER AS: 'STENT - CRIMPING DIFFICULTY' COULD NOT BE EVALUATED DUE TO THE RECEIVED CONDITIONS OF THE DEVICE. ACCORDING TO THE OBSERVED CONDITIONS, IT APPEARS THAT THE STENT HAD NOT BEEN USED PROPERLY. IT WAS NOT POSSIBLE TO DETERMINE THE ROOT CAUSE FOR THE BENDS AND SEVERE DAMAGE IN THE STENT. THE ROOT CAUSE OF THIS FAILURE CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER THE DEVICE DID NOT PRESENT ANY OBVIOUS INDICATIONS OF MANUFACTURING DEFECT OR ANOMALIES THAT MAY HAVE CONTRIBUTED TO THE EVENT REPORTED. THE RECORDS INDICATED THAT THE PRODUCT MET SPECIFICATIONS PRIOR TO SHIPMENT; THEREFORE NO CORRECTIVE OR PREVENTIVE ACTIONS WILL BE TAKEN AT THIS TIME. IN ADDITION, (B)(4) STATES THAT THERE IS NOTHING IN THE (B)(4) DHR THAT INDICATES THIS TYPE OF DAMAGE HAD OCCURRED AND IT IS EXTREMELY UNLIKELY THIS PART WOULD HAVE PASSED (B)(4) INSPECTION PROCESS IF THE DAMAGE HAD OCCURRED AT (B)(4). BASED ON THE INFORMATION AVAILABLE, IT APPEARS THAT THE DIFFICULTY EXPERIENCED MAY HAVE BEEN CAUSED BY THE OPERATIONAL CONTEXT OF THE DEVICE AND IS NOT RELATED TO A PRODUCT QUALITY ISSUE.

    Description of Event or Problem · 1

    AS REPORTED BY AN AFFILIATE, DURING A TRIPLE GRAFT STENTING CASE, A LITTLE LEAK WAS FOUND. THEREFORE, THEY USED PALMAZ UNMOUNTED STENT (STENT PER 50MM X-LARGE). AFTER MOUNTING STENT ON A BALLOON, STENT ITSELF HAD LOOSENED A BIT SO THAT THEY USE ANOTHER GRAFT STENTING OVERLAPED (NON-CORDIS). IT WAS NOTED THAT THE STENT WAS PROPERLY MOUNTED ON THE SYSTEM WHEN INSPECTED PRIOR TO USE. THE SDS WAS PREPPED ACCORDING TO IFU GUIDELINES. THE DIFFICULTY DID OCCUR WHILE THE DEVICES WERE BEING PRELOADED OUTSIDE OF THE PATIENT. ONLY THE DEVICE WAS REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21471 PALMAZ XL STENT PER 50MM OUS ENDOVASCULAR SDS/STENTS FGE CORDIS CORPORATION NA N0809306

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening