BEUDAMED
    FDA Adverse Event Injury Summary report: N

    COMPLETE SE PERIPHERAL STENT SYSTEM

    MDR report key: 2190965 · Received July 28, 2011

    Report

    Report Number
    9612164-2011-00852
    Event Type
    Injury
    Date Received
    July 28, 2011
    Date of Event
    December 21, 2011
    Report Date
    August 1, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS: (RESTENOSIS OF STENTED SEGMENT), (ROOT CAUSE OF RESTENOSIS UNK).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    TARGET LESION INITIALLY REPORTED AS MID LEFT SFA CONFIRMED AS LEFT DISTAL SFA.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, 2 COMPLETE SE STENTS WERE IMPLANTED TO THE MID LEFT SFA. APPROX 12 MONTHS POST INDEX PROCEDURE, BILATERAL CLAUDICATION WAS REPORTED. ANGIOGRAM SHOWED DIFFUSE IN-STENT RESTENOSIS OF THE LEFT SFA STUDY STENTS WITH A FOCAL 80% STENOSIS AND SEVERAL AREAS OF 60% STENOSIS. A TARGET LESION REVASCULARIZATION WAS PERFORMED BY SURGERY. INVESTIGATOR REPORTED A POSSIBLE RELATIONSHIP TO THE DEVICE. PT RECOVERED WITH TREATMENT. REFERENCE MFR REPORT NUMBER 9612164-2011-00853.

    Description of Event or Problem · 1

    APPROXIMATELY 19 MONTHS POST INDEX PROCEDURE, THE REVIEW OF PATIENT'S ARTERIOGRAMS CONFIRMED BILATERAL SFA DISEASE AND ANKLE-BRACHIAL INDICES CONSISTENT WITH CLAUDICATION. THE PATIENT WAS REHOSPITALIZED AND UNDERWENT AN AORTOBIFEMORAL ANEURYSMORRHAPHY WITH BILATERAL PROFUNDOPLASTIES; THE PROXIMAL ANASTOMOSIS WAS AN END-TO END TO THE INFRARENAL AORTA AND THE DISTAL ANASTOMOSES WERE END-TO SIDE TAKEN DOWN BILATERALLY ON THE COMMON FEMORAL ARTERIES ON TO THE PROFUNDA. THE PATIENT WAS DISCHARGED HOME 6 DAYS POST PROCEDURE.

    Description of Event or Problem · 1

    APPROXIMATELY 30 MONTHS POST THE INDEX PROCEDURE THE PATIENT IN-STENT STENOSIS OF THE LEFT SFA STENTS. BALLOON ONLY INTERVENTION WAS CARRIED OUT AND THE PATIENT RECOVERED. THE INVESTIGATOR HAS ASSESSED THAT THE EVENT WAS POSSIBLY RELATED TO THE STUDY DEVICES. APPROXIMATELY 35 MONTHS POST THE INDEX PROCEDURE IT WAS NOTED THAT THE PATIENT HAD RESTENOSIS OF THE LEFT SFA STENTS. NO INTERVENTION WAS CARRIED OUT. THE INVESTIGATOR HAS NOT ASSESSED THE RELATIONSHIP BETWEEN THE EVENT AND THE STUDY DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE PERIPHERAL STENT SYSTEM NIO MEDTRONIC CARDIOVASCULAR NA V00167534

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention