BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 5352458 · Received January 7, 2016

    Report

    Report Number
    2024168-2016-00082
    Event Type
    Injury
    Date Received
    January 7, 2016
    Date of Event
    December 16, 2015
    Report Date
    January 18, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE STENT REMAINS IN THE PATIENT. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). THERE WAS NO REPORTED DEVICE MALFUNCTION. THE PRODUCT WAS NOT RETURNED AS IT REMAINS IN THE PATIENT. THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT. THE JOB TRAVELER FOR THE REPORTED LOT REVEALED NO NONCONFORMING REPORTS (NCR) INDICATING ALL UNITS PASSED QUALITY ASSURANCE (QA) VERIFICATION. THE REPORTED PATIENT EFFECT OF STENOSIS IS A KNOWN POTENTIAL PATIENT EFFECT AS LISTED IN THE SUPERA INSTRUCTIONS FOR USE. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED, THERE IS NO INDICATION THE REPORTED PATIENT EFFECTS WERE CAUSED BY OR RELATED TO THE DESIGN, MANUFACTURE OR LABELING OF THE DEVICE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT POST-STENTING PROCEDURE OF (B)(6) 2015 WITH A 5.5 X 150MM SUPERA STENT IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA), THE PATIENT WAS RE-ADMITTED WITH RESTENOSIS (ISR). THE VESSEL WAS PREPARED USING A 5 X 100 MM UNSPECIFIED BALLOON DILATATION CATHETER AT 8, 8, AND 14 ATMOSPHERE. TREATMENT OF ISR INCLUDED 2.0 LASER ATHERECTOMY AND PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) USING A 5 X 250 MM BALLOON AT 10 ATM. THERE WAS NO REPORTED ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9712 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING STENT SYSTEM NIP AV-TEMECULA-CT 02406062

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R