BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM

    MDR report key: 4047822 · Received August 29, 2014

    Report

    Report Number
    2024168-2014-05571
    Event Type
    Injury
    Date Received
    August 29, 2014
    Date of Event
    February 1, 2014
    Report Date
    August 8, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT PRODUCTS: STENT: 6.0MMX60MMX135CM ABSOLUTE PRO, 5.0MMX40MMX120CM SUPERA, 4.0MMX80MMX120CM SUPERA. THE 6.0MMX60MMX135CM ABSOLUTE PRO, 5.0MMX40MMX120CM SUPERA, AND THE ADDITIONAL 4.0MMX80MMX120CM SUPERA MENTIONED ARE BEING FILED UNDER SEPARATE MANUFACTURER REPORT NUMBERS. DATE OF EVENT ESTIMATED. THERAPY DATE ESTIMATED. THERE WAS NO REPORTED DEVICE MALFUNCTION AND THE PRODUCT WAS NOT RETURNED. THE REPORTED PATIENT EFFECTS OF RESTENOSIS AND CLAUDICATION ARE LISTED IN THE SUPERA INSTRUCTIONS FOR USE (IFU). THE JOB TRAVELER FOR THE REPORTED LOT REVEALED NO NONCONFORMING REPORTS (NCR) INDICATING ALL UNITS PASSED QUALITY ASSURANCE (QA) VERIFICATION. BASED ON THE INFORMATION REVIEWED, THERE IS NO EVIDENCE TO INDICATE THE PRESENCE OF A PRODUCT DEFICIENCY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DUE TO WEAKNESS AND DECREASED CIRCULATION IN THE LEG, ON (B)(6) 2012 THE 6.0MMX60MMX135CM ABSOLUTE PRO STENT WAS DEPLOYED IN THE LEFT FEMORAL ARTERY. DURING ROUTINE FOLLOW-UP, OCCLUSION WAS NOTED IN THE DEPLOYED 6.0MMX60MMX135CM ABSOLUTE PRO STENT; HOWEVER, IT IS UNKNOWN IF THE OCCLUSION WAS DUE TO RESTENOSIS OR THROMBOSIS. AS TREATMENT, A 5.0MMX40MMX120CM SUPERA STENT WAS DEPLOYED ON (B)(6) 2013. ON (B)(6) 2013, TWO 4.0MMX80MMX120CM SUPERA STENTS WERE DEPLOYED TO TREAT ANOTHER LESION IN THE LEFT LEG. REPORTEDLY, THE PATIENT HAS BEEN EXPERIENCING INTERMITTENT PAIN AND WEAKNESS IN THE LEFT LEG AFTER WALKING FOR LONG PERIODS. THE WEAKNESS HAS BEEN OCCURRING PRIOR TO THE DEPLOYMENT OF THE INITIAL STENT; HOWEVER, THE PAIN HAS BEEN ONGOING SINCE DEPLOYMENT OF THE INITIAL STENT. THE PATIENT BEGAN TAKING PLAVIX AND ASPIRIN AFTER THE INITIAL PROCEDURE; HOWEVER, THE PATIENT STOPPED TAKING BOTH BECAUSE OF STOMACH ISSUES EXPERIENCED WHEN TAKING THEM. REPORTEDLY, RESTENOSIS IN THE LEFT LEG HAS BEEN NOTED DURING AN ULTRASOUND IN (B)(6) 2014; HOWEVER, IT IS UNKNOWN WHICH STENT(S) ARE RESTENOSED. REPORTEDLY, FURTHER TREATMENT OF THE LEFT LEG HAS BEEN RECOMMENDED; HOWEVER, NO PROCEDURE HAS BEEN SCHEDULED AND IT IS CURRENTLY UNKNOWN IF ANY TREATMENT WILL BE PERFORMED. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527440 SUPERA PERIPHERAL SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 02122053

    Patients

    Seq Age Sex Outcome Treatment
    1 Disability