BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PALMAZ GENESIS ON AMIIA

    MDR report key: 1903699 · Received November 20, 2010

    Report

    Report Number
    9610978-2010-00246
    Event Type
    Injury
    Date Received
    November 20, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    CORDIS EUROPA, N.V.
    Product Code
    FGE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED. DURING A STENTING PROCEDURE TO THE RENAL ARTERY, THE BALLOON WAS REPORTED TO HAVE RUPTURED DURING STENT DEPLOYMENT AT 10 ATMOSPHERES. THE STENT WAS THEN POST DILATED TO FULLY EXPAND IT. THE VESSEL WAS DESCRIBED AS HAVING NO CALCIFICATION OR VESSEL TORTUOSITY WITH AN UNKNOWN RATE OF STENOSIS. THERE WAS NO REPORTED PATIENT INJURY. A REVIEW OF THE MANUFACTURING DOCUMENTATION ASSOCIATED WITH THIS LOT PRESENTED NO ISSUES DURING THE MANUFACTURING PROCESS THAT CAN BE RELATED TO THE REPORTED COMPLAINT. REVIEW OF LOT 15209172 REVEALED NO ANOMALIES DURING THE MANUFACTURING AND INSPECTION PROCESSES THAT CAN BE ASSOCIATED WITH THE REPORTED COMPLAINT. INFLATION/DEFLATION AND BURST TEST RESULTS WERE REVIEWED AND NO ANOMALIES WERE FOUND DURING MANUFACTURING PROCESS OF THESE LOTS. BASED ON THE LACK OF INFORMATION AND THE INABILITY TO ASSIGN OR DETERMINE ROOT CAUSE NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME. WITH THE LIMITED AMOUNT OF INFORMATION AVAILABLE AND WITHOUT RETURN OF THE PRODUCT FOR ANALYSIS OR FILMS OF THE EVENT, IT IS NOT POSSIBLE TO DRAW A CLINICAL CONCLUSION BETWEEN THE DEVICE AND THE EVENT. HOWEVER, VESSEL CHARACTERISTICS AND PROCEDURAL FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT IS AVAILABLE, BUT HAS NOT BEEN RECEIVED AS OF THE INITIAL REPORT. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    RPTA: THE TARGET LESION WAS RENAL ARTERY. THE PATIENT WAS A (B)(6) FEMALE. NO CALCIFICATION OR VESSEL TORTUOSITY, THE RATE OF STENOSIS WAS UNKNOWN. THE 6.0X15 142CM PALMAZ GENESIS ((B)(4), COMPLAINT PRODUCT) WAS DELIVERED, BUT THE BALLOON RUPTURED AT 10ATM DURING THE INFLATION USING AN INDEFLATOR (EVEREST, MEDTRONIC). THE DEVICE WAS SAFELY REMOVED FROM THE PATIENT. AS THE STENT WAS NOT EXPANDED ENOUGH, AVIATOR PLUS (424-6015W, (B)(4)) WAS USED FOR POST-DILATATION AND THE PROCEDURE WAS COMPLETED WITHOUT ANY OTHER ISSUES. THERE WAS NO ADVERSE EVENT AND THE PATIENT IS IN STABLE CONDITION. ONLY THE AVIATOR PLUS WILL BE RETURNED TO YOUR SIDE FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALMAZ GENESIS ON AMIIA ENDOVASCULAR SDS/STENTS (FGE) FGE CORDIS EUROPA, N.V. 15209172

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR