BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUPERA SELF-EXPANDING STENT SYSTEM

    MDR report key: 11346786 · Received February 18, 2021

    Report

    Report Number
    2024168-2021-01314
    Event Type
    Malfunction
    Date Received
    February 18, 2021
    Date of Event
    January 28, 2021
    Report Date
    March 18, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    NIP
    UDI-DI
    08717648226168
    PMA / PMN Number
    P120020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. 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 THAT CASE CIRCUMSTANCES CONTRIBUTED TO THE REPORTED DIFFICULTIES. IT IS LIKELY THAT THE SUPERA DEVICE ENCOUNTERED RESISTANCE DURING ADVANCEMENT WITH THE HEAVILY CALCIFIED, 90% STENOSED, DE NOVO, MID-DISTAL SUPERFICIAL FEMORAL ARTERY (SFA) AND WHILE DEPLOYING THE STENT. AS A RESULT, THE STENT ELONGATED WITH CONTINUAL RESISTANCE THROUGHOUT REMOVAL OF THE STENT AND DELIVERY SYSTEM FROM THE ANATOMY. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.D9, H3 - DEVICE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS EXPECTED TO BE RETURNED FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE OTHER SUPERA DEVICE REFERENCED IS FILED UNDER A SEPARATE MEDWATCH REPORT NUMBERS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, 90% STENOSED, DE NOVO, MID-DISTAL SUPERFICIAL FEMORAL ARTERY (SFA). A 5.5X150MM SUPERA PERIPHERAL STENT SYSTEM (SES) (LOT#9062761) WAS ADVANCED WITH RESISTANCE TOWARDS THE DISTAL LESION. DEPLOYMENT WAS INITIATED, BUT SIGNIFICANT ELONGATION OCCURRED, SO BOTH THE STENT AND THE STENT DELIVERY SYSTEM WERE REMOVED, WITH SOME RESISTANCE NOTED. A 5.0X150MM SUPERA SES WAS IMPLANTED IN THE DISTAL LESION WITHOUT ISSUE. ANOTHER 5.5X150MM SUPERA PERIPHERAL STENT SYSTEM (SES) (LOT#9062861) WAS ADVANCED WITH RESISTANCE TOWARDS THE PROXIMAL LESION. DEPLOYMENT WAS INITIATED, BUT SIGNIFICANT ELONGATION OCCURRED, SO BOTH THE STENT AND THE STENT DELIVERY SYSTEM WERE REMOVED, WITH SOME RESISTANCE NOTED. THE LESION WAS AGAIN PRE-DILATED. A 5X120MM SUPERA SES WAS IMPLANTED IN THE PROXIMAL LESION, OVERLAPPING THE INITIAL STENT, TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238640 SUPERA SELF-EXPANDING STENT SYSTEM SELF EXPANDING PERIPHERAL STENT SYSTEM NIP ABBOTT VASCULAR S-55-150-120-P6 9062761 08717648226168

    Patients

    Seq Age Sex Outcome Treatment
    1