BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RACER BILIARY PERIPHERAL STENT SYSTEM

    MDR report key: 1901565 · Received November 12, 2010

    Report

    Report Number
    2953200-2010-02226
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    FGE
    PMA / PMN Number
    K032768
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): EVAL RESULTS/CONCLUSIONS: (STENOTIC LESION, RESISTANT TO BALLOONING), (RACER BILIARY IS APPROVED FOR USE IN PALLIATION OF MALIGNANT NEOPLASMS IN THE BILIARY TREE).

    Description of Event or Problem · 1

    A RACER BILIARY PERIPHERAL STENT SYSTEM, DIAMETER 6MM, LENGTH 18MM, WAS USED TO TREAT LESION IN A PT'S LEFT RENAL ARTERY. IT WAS REPORTED THAT A POSSIBLE STENT FRACTURE / WELD FRACTURE WAS NOTED AFTER DEPLOYMENT OF THE STENT AT NOMINAL PRESSURE. IT WAS REPORTED THAT THE STENT WAS POST DILATED TO 10ATMS. AN ADD'L RACER STENT WAS IMPLANTED TO THE LESION TO COVER THE REPORTED STENT FRACTURE. THE PT WAS FINE POST PROCEDURE AND NO CLINICAL SEQUELAE HAVE BEEN REPORTED. CD REVIEW: A CD OF PROCEDURAL IMAGES WAS RETURNED TO MEDTRONIC FOR EVAL. THE PROCEDURAL IMAGES CONFIRMED THE PRESENCES OF STENOTIC LESIONS IN BOTH RENAL ARTERIES. THE TARGET LESION WAS LOCATED ON A BEND BETWEEN THE OSTIUM AND THE PROXIMAL LEFT RENAL ARTERY. IMAGES CONFIRM THE PRE-DILATION OF THE LESION PRIOR TO THE DEPLOYMENT OF THE 6 X 18MM RACER STENT. THE LESION APPEARED TO BE PARTIALLY RESISTANT TO BALLOONING AS A WAIST THAT WAS EVIDENT IN THE BALLOON DURING PRE-DILATATION. THIS WAIST WAS STILL APPARENT DURING THE STENT DEPLOYMENT. THE "WAIST" IN THE STENT AND VESSEL APPEARED TO BE RESOLVED DURING POST-DILATATION OF THE STENT AT 10ATMS. IMAGES OF THE STENT AFTER POST DILATATION APPEAR TO SHOW A SEPARATION BETWEEN THE 2ND AND 3RD STENT SEGMENTS. THERE WAS NO EVIDENCE OF STENT WELD/JOINT BREAKAGE BASED ON THE IMAGES PROVIDED. THE IMAGES ALSO SHOWED THE DEPLOYMENT OF THE BAIL-OUT STENT AND THE DEPLOYMENT OF ANOTHER STENT IN THE RIGHT RENAL ARTERY. RECREATIONS OF STENT DEPLOYMENT ON A CURVE OR BEND AT NOMINAL PRESSURE HAVE SHOWN THAT GAPPING OR STENT MATERIAL DISTORTION CAN OCCUR WHEN THE STENT IS DEPLOYED ON A BEND AS A RESULT OF PREVIOUSLY ADJACENT NON WELDED SEGMENTS BEING FORCED OUT OF ALIGNMENT DUE TO THE VESSEL MORPHOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RACER BILIARY PERIPHERAL STENT SYSTEM FGE MEDTRONIC CARDIOVASCULAR NA 0001067859

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention