BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SOLITAIRE AB STENT

    MDR report key: 12850155 · Received November 21, 2021

    Report

    Report Number
    2029214-2021-01511
    Event Type
    Malfunction
    Date Received
    November 21, 2021
    Date of Event
    August 2, 2021
    Report Date
    November 21, 2021
    Manufacturer
    MICRO THERAPEUTICS, INC. DBA EV3
    Product Code
    NJE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT ANALYSIS : ¿ AS FOUND CONDITION: THE SOLITAIRE AB STENT WAS RETURNED FOR ANALYSIS WITHIN A SHIPPING BOX, WITHIN A PLASTIC POUCH, AND WITHIN AN OPENED SOLITAIRE AB INNER POUCH (B110753). THE SOLITAIRE AB STENT WAS RETURNED WITHOUT THE PUSHER OR INTRODUCER SHEATH. ¿ VISUAL INSPECTION/DAMAGE LOCATION DETAILS: THE STENT NON-WORKING (TEARDROP) STRUTS WERE FOUND BENT AND BROKEN. THE STENT WORKING LENGTH STRUTS WERE FOUND IN GOOD CONDITION ¿ TESTING/ANALYSIS: THE SOLITAIRE AB STENT WAS SENT OUT FOR SEM (SCANNING ELECTRON MICROSCOPY) ANALYSIS FOR FAILURE ANALYSIS OF THE BROKEN STRUTS. PER THE ANALYSIS REPORT, ¿MULTIPLE FATIGUE CRACKING AREAS ARE VISIBLE FOR BOTH STRUT ENDS. ALL FATIGUE CRACKING INITIATED FROM THE WIRE OUTER SURFACES. THE REST FRACTURES FAILED VIA OVERLOAD.¿ THIS LIKELY INDICATES THE STRUT BECAME BENT BEFORE BREAKING. ¿ CONCLUSION: BASED ON THE DEVICE ANALYSIS AND REPORTED INFORMATION, THE CUSTOMER¿S REPORT OF ¿SEPARATION¿ WAS CONFIRMED. HOWEVER, THE CUSTOMER¿S ¿STENT RESISTANCE/STUCK IN SHEATH¿ REPORT COULD NOT BE CONFIRMED AS THE INTRODUCER SHEATH WAS NOT RETURNED. AS THE INTRODUCER SHEATH WAS NOT RETURNED ANY CONTRIBUTING FACTORS COULD NOT BE ASSESSED. FROM THE DAMAGES SEEN WITH THE RETURNED SOLITAIRE AB STENT IT APPEARS EXCESSIVE FORCE MAY HAVE BEEN USED. IT IS LIKELY THE STENT BECAME DAMAGED (BENT) DURING THE ATTEMPT TO DELIVER THROUGH THE INTRODUCER SHEATH, SUBSEQUENTLY BREAKING UPON REMOVAL. THE INVESTIGATION DETERMINED THAT THIS EVENT WAS SIMILAR TO AN EVENT THAT HAD ALREADY BEEN INVESTIGATED, AND ANOTHER INVESTIGATION IS NOT NECESSARY (SEE (B)(4) SOLITAIRE SEPARATION) ((B)(4)), IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 0

    MEDTRONIC RECEIVED INFORMATION REPORTING THAT A SOLITAIRE AB (SAB) COULD NOT BE PUSHED OUT OF THE SHEATH AND IT WAS NOTED THE PUSHWIRE HAD BROKEN AT THE DISTAL END IN THE SHEATH AFTER INSPECTION. IT WAS NOTED THE SAB WAS PREPARED AS INDICATED IN THE INSTRUCTIONS FOR USE (IFU). THERE HAD NOT BEEN ANY RESISTANCE. THE DEVICE WAS NOT USED IN THE PATIENT'S BODY SO THERE WAS NO HARM OR INJURY TO THE PATIENT. ADDITIONAL INFORMATION WAS RECEIVED REPORTED THAT THE TIP OF THE SHEATH WAS SECURED IN THE HUB OF THE MICROCATHETER. THE RHV WAS SECURED DURING DELIVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1747696 SOLITAIRE AB STENT INTRACRANIAL NEUROVASCULAR STENT NJE MICRO THERAPEUTICS, INC. DBA EV3 SAB-6-30 B110753

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male