BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUPERA

    MDR report key: 20465823 · Received October 16, 2024

    Report

    Report Number
    2024168-2024-12209
    Event Type
    Injury
    Date Received
    October 16, 2024
    Date of Event
    May 2, 2024
    Report Date
    November 15, 2024
    Manufacturer
    ABBOTT VASCULAR INC.
    Product Code
    NIP
    UDI-DI
    08717648211812
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION IS STILL PENDING AT THIS TIME. RESULTS AND CONCLUSIONS WILL BE PROVIDED IN THE FINAL REPORT. D4: A PARTIAL UDI NUMBER IS ENTERED AS THE LOT NUMBER WAS NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. ELECTRONIC LOT HISTORY RECORD (ELHR) AND CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE SUPERA PERIPHERAL STENT SYSTEMS INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT. A CONCLUSIVE CAUSE FOR THE REPORTED OBSTRUCTION/ OCCLUSION, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE TREATMENT APPEARS TO BE RELATED TO THE OPERATIONAL CONTEXT OF THE PROCEDURE. BASED ON THE REPORTED INFORMATION AND RESULTS OF THE COMPLAINT INVESTIGATION THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. CORRECTIONS: A2 - AGE UNITS (PATIENT): UPDATED FROM NI TO 74 YEARS A2 - DOB: UPDATED FROM NI TO (B)(6) 1949 A2 - DOB: UPDATED FROM NI TO MALE A4 - WEIGHT: UPDATED FROM NI TO 79 KG D4 - LOT #: UPDATED FROM UNKNOWN TO 2092461 D4 - PRIMARY UDI NUMBER: UPDATED FROM (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT ON (B)(6) 2024, A 6.0X80X120 SUPERA STENT WAS IMPLANTED IN THE LEFT POPLITEAL ARTERY DUE TO 75% STENOSIS. POST PROCEDURE, PATIENT WAS COMPLIANT WITH DUAL ANTIPLATELET DRUG THERAPY CONSISTING OF PLAVIX 75MG AND ASPIRIN 81MG. A FOLLOW UP PERCUTANEOUS INTERVENTION WAS SCHEDULED AND PERFORMED ON (B)(6) 2024. DURING THIS PROCEDURE, IN-STENT RESTENOSIS OF THE SUPERA STENT WAS DISCOVERED, ALTHOUGH THE PATIENT REMAINED ASYMPTOMATIC. THEREFORE, LASER ATHERECTOMY AND AN UNSPECIFIED DRUG-COATED BALLOON WERE USED AS TREATMENT AND THE STENT WAS CONFIRMED TO BE PATENT. THERE WERE NO ADVERSE PATIENT SEQUELA. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1033620 SUPERA STENT, SUPERFICIAL FEMORAL ARTERY NIP ABBOTT VASCULAR INC. S-60-080-120-P6 2092461 08717648211812

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention UNSPECIFIED DRUG-COATED BALLOON.