BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARCHER GUIDEWIRE

    MDR report key: 2914488 · Received January 14, 2013

    Report

    Report Number
    2953200-2013-00086
    Event Type
    Injury
    Date Received
    January 14, 2013
    Date of Event
    December 16, 2012
    Report Date
    March 8, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    DQX
    PMA / PMN Number
    K101339
    Removal / Correction Number
    Z-1019-2013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TU
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: LACK OF INFORMATION (UNKNOWN CAUSE OF DETACHMENT). CONCLUSION: LACK OF INFORMATION (UNKNOWN CAUSE OF DETACHMENT).

    Additional Manufacturer Narrative · 1

    METHOD: (FILM).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THIS SUPPLEMENTAL REPORT IS BEING RETROSPECTIVELY FILED TO REPORT MANUFACTURING RELATED ISSUE THAT WAS SUBMITTED UNDER Z-1019-2013.

    Description of Event or Problem · 1

    FILMS PRE-IMPLANT WERE FROM A DIAGNOSTIC ANGIO PROCEDURE. THE ARCH WAS MODERATELY ANGULATED AND THE DESCENDING THORACIC WAS STRAIGHT. A TAA WAS NOT CLEARLY IDENTIFIABLE. ANGIO IMAGES AT IMPLANT SHOW THAT A LARGE PROXIMAL SECTION OF THE WIRE HAS BROKEN OFF. IMAGES DURING THE DETACHMENT WERE NOT PROVIDED. THE PROXIMAL TIP OF THE BROKEN WIRE WAS NEAR THE HEART VALVE, AND THE DISTAL END OF THE BROKEN SEGMENT APPEARED TO BE WITHIN THE LSA. WITH THE BROKEN PROXIMAL WIRE SEGMENT STILL INSIDE THE THORACIC AORTA, AN IMAGE OF THE IMPLANTED VALIANT STENT GRAFT WAS SEEN. WITH THE DELIVERY SYSTEM STILL WITHIN THE STENT GRAFT, NO OBVIOUS STENT GRAFT ISSUES WERE OBSERVED. THE WIRE APPEARED TO HAVE PERFORATED THE LSA, AS VISIBLE CONTRAST WAS SEEN EXITING THE LSA. IMAGES POST PROXIMAL WIRE REMOVAL WERE NOT PROVIDED; THEREFORE IT IS UNKNOWN IF THE LSA PERFORATION REMAINED AFTER REMOVAL OF THE DETACHED WIRE FROM THE THORACIC/LSA.

    Description of Event or Problem · 1

    THE WIRE WAS RETURNED AND ITS EVALUATION HAS BEEN COMPLETED. UPON INVESTIGATION OF THE WIRE, IT WAS DETERMINED THAT IT WAS DETACHED AT THE PROXIMAL WELD. THERE WAS ALSO A COIL SEPARATION 10.2 CM FROM THE PROXIMAL WELD. THE CAUSE OF THE DETACHMENT IS CURRENTLY UNKNOWN.

    Description of Event or Problem · 1

    AN ARCHER GUIDEWIRE WAS USED AS AN ACCESSORY PRODUCT IN A PATIENT DURING THE ENDOVASCULAR TREATMENT OF AN AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS DESCRIBED AS NONE CALCIFIED AND MODERATE TORTUOSITY. IT WAS REPORTED THAT AN ARCHER WIRE WAS ADVANCED THROUGH THE AORTIC ARCH AND AN UNKNOWN MANUFACTURER'S STENT GRAFT DELIVERY SYSTEM WAS ADVANCED THROUGH THE FEMORAL ARTERY OVER THE ARCHER WIRE. WHEN THE STENT GRAFT DELIVERY SYSTEM REACHED THE DISTAL SEGMENT OF THE LSA, THE ARCHER WIRE SEPARATED INTO TWO PIECES. THE SOFT FLEXIBLE PART OF THE WIRE WENT THROUGH THE ARCH AND THE STIFF CORE PART WENT INTO THE LSA. THE LONG PORTION OF THE WIRE WAS WITHIN THE STENT GRAFT DELIVERY SYSTEM. THE PHYSICIAN REMOVED THE DELIVERY SYSTEM AND LONGER PORTION OF THE WIRE OUT OF THE PATIENT VIA THE FEMORAL ARTERY. DUE TO THE WIRE'S POSITION IN THE LSA THE PHYSICIAN COULD NOT SNARE OUT THE SHORT FLEXIBLE PART OF THE ARCHER AND HAD TO CONVERT TO OPEN SURGERY TO REMOVE THE WIRE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19875 ARCHER GUIDEWIRE WIRE, GUIDE, CATHETER DQX MEDTRONIC CARDIOVASCULAR GFWC0195

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention