BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROXIMATE*ILS CURVED CIR STAPL

    MDR report key: 1911711 · Received December 1, 2010

    Report

    Report Number
    3005075853-2010-06769
    Event Type
    Malfunction
    Date Received
    December 1, 2010
    Date of Event
    November 10, 2010
    Report Date
    November 10, 2010
    Manufacturer
    ETHICON ENDO-SURGERY, LLC.
    Product Code
    GDW
    PMA / PMN Number
    K983536
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS RESULTS FOUND THAT THE DEVICE ARRIVED IN GOOD VISUAL CONDITION. THE BREAKAWAY WASHER WAS PRESENT AND CUT AND THERE WERE NO STAPLES PRESENT, INDICATING THAT THE DEVICE ACHIEVED A FULL FIRING STROKE. THE DEVICE WAS RELOADED WITH STAPLES, A NEW WASHER WAS PLACED ON THE DEVICE AND IT WAS TESTED FOR FUNCTIONALITY. IT FIRED AND FORMED ALL THE STAPLES AS WELL AS COMPLETELY CUT THE TEST MEDIA AND THE BREAKAWAY WASHER WITHOUT INCIDENT. THE STAPLE LINE WAS COMPLETE AND THE STAPLES WERE NOTED TO HAVE THE PROPER B-FORMED SHAPE. A BATCH RECORD REVIEW WAS PERFORMED AND NO ANOMALIES WERE FOUND DURING THE MANUFACTURING PROCESS.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 31 MONTHS AGO. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNK. THE INFRARENAL AORTIC NECK WAS SHORT AND MEASURED 35 MM IN DIAMETER AND THEN PINCHED DOWN TO LESS THAN 26 MM IN DIAMETER. THE PT WAS NOT A SURGICAL CANDIDATE. IT WAS REPORTED THAT DUE TO THE DIFFICULT NECK ANATOMY, AN ANEURX CUFF WAS ALSO IMPLANTED PROXIMALLY IN A PLANNED PLACEMENT; HOWEVER, THE ORIGINAL PLACEMENT POSITION OF THE CUFF IS UNK. THE PT WAS LOST TO F/U AND PRESENTED EMERGENTLY ON (B)(4) 2010, WITH PROXIMAL TYPE 1 ENDOLEAK AND A RUPTURED ANEURYSM. THE CUFF WAS LOCATED 15 MM BELOW THE RENAL ARTERIES, BUT STENT GRAFT MIGRATION CANNOT BE CONFIRMED. THE PHYSICIAN CONVERTED THE PT TO AN OPEN REPAIR AND EXPLANTED THE STENT GRAFTS (SEE MFR # 2953200-2010-02530). THE EXPLANTED STENT GRAFTS WERE DISCARDED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND NO FURTHER INFO WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE STAPLE LINE WAS INCOMPLETE AFTER FIRING. IT WAS NOT REPORTED HOW THE PROCEDURE WAS COMPLETED. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROXIMATE*ILS CURVED CIR STAPL STAPLE, IMPLANTABLE GDW ETHICON ENDO-SURGERY, LLC. G4T00D

    Patients

    Seq Age Sex Outcome Treatment
    1