BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPERA

    MDR report key: 20287692 · Received September 23, 2024

    Report

    Report Number
    2024168-2024-11222
    Event Type
    Death
    Date Received
    September 23, 2024
    Date of Event
    September 1, 2022
    Report Date
    September 23, 2024
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    PMA / PMN Number
    P120020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) REVIEW WAS PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A ELECTRONIC LOT HISTORY RECORD (ELHR) REVIEW AND A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS NOT PERFORMED BECAUSE THE PART AND LOT NUMBER WAS NOT REPORTED. THE REPORTED PATIENT EFFECT OF OCCLUSION IS LISTED IN THE SUPERA PERIPHERAL STENT SYSTEMS INSTRUCTIONS FOR USE (IFU) AS A POTENTIAL ADVERSE EFFECT. A CONCLUSIVE CAUSE FOR THE REPORTED DEATH AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THE TREATMENT(S) 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. B3: DATE OF EVENT: FOR REPORTING PURPOSES, THE DATE OF PROCEDURE WILL BE (B)(6) 2021 AS THIS 24 MONTHS PRIOR FROM THE 2 YEAR FOLLOW-UP. DATE OF EVENT WILL BE (B)(6) 2022 AS THIS IS THE 1 YEAR FOLLOW-UP WHERE ADVERSE EVENTS WERE NOTED. B2 - DATE OF DEATH - ESTIMATED DATE. D4 - PRIMARY UDI NUMBER - THE UDI IS NOT KNOWN AS THE PART AND LOT NUMBER WERE NOT PROVIDED. THE ADDITIONAL SERIOUS INJURY REPORTED IN THE ARTICLE(S) ARE CAPTURED UNDER SEPARATE REPORT(S). "A MULTICENTER PROSPECTIVE OBSERVATIONAL STUDY APPRAISING THE EFFECTIVENESS OF THE SUPERA STENT AFTER SUBINTIMAL RECANALIZATION OF FEMORO-POPLITEAL ARTERY OCCLUSION: THE SUPERSUB II STUDY".

    Description of Event or Problem · 0

    IT WAS REPORTED IN AN ARTICLE THAT A TOTAL OF 92 PATIENTS ENROLLED ACROSS 15 SITES WERE INCLUDED. OF THESE PATIENTS, EIGHT WERE IDENTIFIED AS MAJOR PROTOCOL VIOLATORS. THE FINAL NUMBER OF SUBJECTS INCLUDED IN THE PER-PROTOCOL ANALYSIS WAS THUS 84. THE SUPERA SELF-EXPANDING STENT SYSTEM (SESS) WAS IMPLANTED IN THE LOWER EXTREMITY. AFTER DISCHARGE, ALL PATIENTS ATTENDED CLINIC VISITS AT 30 DAYS (±14 DAYS), 6 MONTHS (±30 DAYS), 12 MONTHS (±30 DAYS), AND 24 MONTHS (±30 DAYS) THAT WAS THE FINAL VISIT. QUALITATIVE AND QUANTITATIVE ASSESSMENT FOR DIAGNOSTIC AND THERAPEUTIC IMAGING IN ALL ASPECTS OF SELECTIVE CARDIO-VASCULAR DISEASE (QUALITATIVE AND QUANTITATIVE PERIPHERAL ARTERIAL SEGMENTS ANALYSIS, ANGIOGRAPHY/CO2 ANGIOGRAPHY, DUPLEX ULTRASOUND, COMPUTED TOMOGRAPHY SCAN, MAGNETIC RESONANCE ANGIOGRAPHY AND X-RAY VISUALIZATION OF STUDY DEVICE) WAS RECOMMENDED, AS PER LOCAL INSTITUTIONAL PRACTICE. THE PRIMARY EFFICACY ENDPOINT WAS FREEDOM FROM CLINICALLY DRIVEN TARGET LESION REVASCULARIZATION (CD-TLR) AT 12 MONTHS. OTHER EFFICACY ENDPOINTS WERE FREEDOM FROM CD-TLR AT 24 MONTHS, PRIMARY PATENCY RATES AT 12 AND 24 MONTHS. SAFETY ENDPOINTS INCLUDED: FREEDOM FROM DEVICE AND PROCEDURE-RELATED DEATH THROUGH 30 DAYS POST PROCEDURE, FREEDOM FROM TARGET LIMB MAJOR AMPUTATION AND CLINICALLY-DRIVEN TARGET LESION REVASCULARIZATION THROUGH 12 MONTHS POST PROCEDURE, AND UP TO 24 MONTHS, COMPOSITE OF ALL MAJOR ADVERSE EVENTS (MAES), INCLUDING DEATH FROM ANY CAUSE, MAJOR TARGET LIMB AMPUTATION, AND CD-TLR) AT 12 AND 24 MONTHS, AND INDIVIDUAL COMPONENTS OF MAE AT 12 AND 24 MONTHS. OTHER ENDPOINTS OF INTEREST WERE: TECHNICAL SUCCESS (DEFINED AS ACHIEVEMENT OF AN ANGIOGRAPHIC CORE LAB-SANCTIONED FINAL IN LESION RESIDUAL DIAMETER STENOSIS OF =30% USING THE SUPERA STENT AFTER WIRE PASSAGE THROUGH THE LESION, CLINICAL SUCCESS (PER-SUBJECT, DEFINED AS TECHNICAL SUCCESS WITHOUT THE OCCURRENCE OF MAJOR ADVERSE LIMB EVENTS DURING HOSPITALIZATION), PROCEDURAL SUCCESS (PER SUBJECT, DEFINED AS LESION SUCCESS WITHOUT THE OCCURRENCE OF MAJOR ADVERSE EVENTS DURING THE PROCEDURE), AMPUTATION (DISTINGUISHING MAJOR AND MINOR AMPUTATIONS) AT 1, 6, 12, AND 24 MONTHS, PRIMARY SUSTAINED CLINICAL IMPROVEMENT (IMPROVEMENT OF =1 RUTHERFORD CLASS WITHOUT CD-TLR) AT 1, 6, 12, AND 24 MONTHS, CLINICAL IMPROVEMENT AS ASSESSED BY RUTHERFORD CLASS CHANGES AT 1, 6, 12, AND 24 MONTHS, QUALITY OF LIFE IMPROVEMENTS AT 6, 12, AND 24 MONTHS AND STENT INTEGRITY AT 12 AND 24 MONTHS. DETAILS ARE LISTED IN THE ARTICLE TITLED, "A MULTICENTER PROSPECTIVE OBSERVATIONAL STUDY APPRAISING THE EFFECTIVENESS OF THE SUPERA STENT AFTER SUBINTIMAL RECANALIZATION OF FEMORO-POPLITEAL ARTERY OCCLUSION: THE SUPERSUB II STUDY".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1870228 SUPERA SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR UNK SUPERA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death