BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE PERIPHERAL STENT SYSTEM

    MDR report key: 2100469 · Received May 17, 2011

    Report

    Report Number
    9612164-2011-00430
    Event Type
    Malfunction
    Date Received
    May 17, 2011
    Date of Event
    January 10, 2011
    Report Date
    April 20, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED THROUGH CEC. THE PATIENT UNDERWENT THE INDEX PROCEDURE FOR TREATMENT OF ONE LESION. PRE- PROCEDURE BALLOON ANGIOPLASTY WAS PERFORMED. IT IS REPORTED THAT THE LESION IN THE LEFT DISTAL SFA WAS OCCLUDED AND A GRADE D DISSECTION WAS NOTED FOLLOWING PREDILATATION. ONE COMPLETE SELF EXPANDING SUPERFICIAL FEMORAL ARTERY (SFA) STENT WERE DELIVERED IN THE LEFT DISTAL SFA. THE SITE REPORTED THAT THERE WAS "STENT E DISLOCATION WITHIN APPLICATION TO DISTAL" AND A SECOND STENT WAS PLACED PROXIMAL TO AND OVERLAPPING THE FIRST STENT TO COVER THE TARGET LESION. THE PATIENT WAS DISCHARGED ON ASA AND CLOPIDOGREL. DURING THE 30-DAY FOLLOW-UP VISIT, THE PATIENT HAD MODERATE CLAUDICATION. DURING THE 6-MONTH FOLLOW-UP VISIT, PATIENT HAD MILD CLAUDICATION AND THE PATIENT UNDERWENT A NON-TARGET VESSEL REVASCULARIZATION OF THE RIGHT CALF. DURING THE REVASCULARIZATION CARRIED OUT APPROXIMATELY 8 MONTHS POST INDEX PROCEDURE, THE PATIENT UNDERWENT SUCCESSFUL BALLOON ANGIOPLASTY OF THE LEFT SFA.

    Description of Event or Problem · 1

    DURING INDEX PROCEDURE, ONE COMPLETE SE STENT WAS IMPLANTED TO THE LEFT DISTAL SFA AND ONE COMPLETE SE STENT WAS IMPLANTED TO THE LEFT MID SFA. APPROX 8 MONTHS POST INDEX PROCEDURE, INSTENT STENOSIS OF THE LEFT DISTAL AND LEFT MID SFA WAS REPORTED. THE PT WAS HOSPITALIZED AND VASCULAR INTERVENTION WAS PERFORMED (CLINICALLY DRIVE TLR/TVR). PT RECOVERED WITH TREATMENT. INVESTIGATOR REPORTED A DEFINITE RELATIONSHIP TO THE STUDY STENT. REFERENCE MFR REPORT NUMBERS 961264-2011-00431.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COMPLETE SE PERIPHERAL STENT SYSTEM NIO MEDTRONIC CARDIOVASCULAR NA V00173919

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention