BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM

    MDR report key: 10248283 · Received July 8, 2020

    Report

    Report Number
    2024168-2020-05570
    Event Type
    Malfunction
    Date Received
    July 8, 2020
    Date of Event
    June 18, 2020
    Report Date
    August 11, 2020
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    UDI-DI
    08717648176159
    PMA / PMN Number
    P110028
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RETURNED FOR ANALYSIS. VISUAL TESTING WAS PERFORMED ON THE RETURNED DEVICE. THE VISIBILITY ISSUE WAS NOT CONFIRMED AS THE IMAGE CLEARLY SHOWED THE BALLOON MARKERS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS REPORTED FROM THIS LOT. THE INVESTIGATION DETERMINED THE REPORTED DIFFICULTIES ARE CASE CIRCUMSTANCES. IT IS LIKELY THAT CHALLENGING ANATOMICAL CONDITIONS CONTRIBUTED TO THE VISIBILITY ISSUE. AS A RESULT, THE STENTS WERE REPORTED TO HAVE NOT DEPLOYED PRIOR TO REACHING THE TARGET LESION, ALTHOUGH THE STENTS WERE LATER CONFIRMED TO HAVE DEPLOYED TO THE TARGET LESION. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    THE DELIVERY SYSTEM IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER TWO ABSOLUTE PRO VASCULAR STENTS REFERENCED IN B5 ARE FILED UNDER SEPARATE MEDWATCH REPORTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT AND LEFT EXTERNAL ILIAC. THE BILATERAL EXTERNAL ILIAC, COMMON ILIAC, AND THE DISTAL AORTA WERE VERY CALCIFIED. SHOCKWAVE THERAPY WAS PERFORMED. THE ABSOLUTE PRO (9090461) WAS ADVANCED HOWEVER IT WAS BELIEVED THE STENT FAILED TO DEPLOY BECAUSE THE STENT MARKERS WERE NOT VISIBLE. THE DEVICE WAS REMOVED WITHOUT ISSUE. THE SAME ISSUE OCCURRED WITH TWO OTHER ABSOLUTE PRO DEVICES (9080861, 9010261); IT WAS BELIEVED THE STENTS COMPLETELY FAILED TO DEPLOY BECAUSE THE STENT MARKERS WERE NOT VISIBLE. NO OTHER ATTEMPTS WERE MADE TO STENT. THE FILMS WERE REVIEWED, THE STENTS WERE CONFIRMED TO HAVE BEEN DEPLOYED IN THE TARGET VESSELS, HOWEVER, THE MARKERS WERE NOT VISIBLE DUE TO THE PATIENT ANATOMY. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS AND NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    709098 ABSOLUTE PRO VASCULAR SELF-EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR 1012536-60 9090461 08717648176159

    Patients

    Seq Age Sex Outcome Treatment
    1