BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN_NEUROVASCULAR_PRODUCT

    MDR report key: 9914361 · Received April 1, 2020

    Report

    Report Number
    3008881809-2020-00083
    Event Type
    Malfunction
    Date Received
    April 1, 2020
    Date of Event
    March 10, 2020
    Report Date
    May 28, 2020
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    D4: EXPIRATION DATE: UPDATED D10: PRODUCT AVAILABLE TO STRYKER: UPDATED H3: DEVICE EVALUATED BY MFG: UPDATED H3: SUMMARY ATTACHED: UPDATED H4: MANUFACTURING DATE: UPDATED H6: DEVICE CODE: CORRECTED DUE TO THE AUTOMATED MES SYSTEM (MANUFACTURING EXECUTION SYSTEM), THERE ARE CONTROLS IN THE MANUFACTURING PROCESS TO ENSURE THE PRODUCT MET SPECIFICATIONS UPON RELEASE. THE REPORTED EVENT IS COVERED IN THE DEVICE DFU. AS WELL, THE RISK OF THE REPORTED EVENT IS DOCUMENTED IN THE RISK DOCUMENTATION AND THERE ARE CURRENT CONTROLS TO MITIGATE THE RISK OF THE AS REPORTED EVENT. THE DEVICE WAS RETURNED INSERTED IN THE CONCURRENT MICROCATHETER AND IT WAS CONFIRMED THAT THE STENT WAS PARTIALLY DEPLOYED. THE SUBJECT DEVICE WAS ADVANCED, THE STENT WAS REMOVED, AND WAS NOTED TO BE DAMAGED. THE CONCURRENT MICROCATHETER WAS NOTED TO BE SEVERELY DAMAGED MID SHAFT TO THE DISTAL SHAFT AND THE CATHETER TIP WAS ALSO DAMAGED. THE SUBJECT STENT STABILIZER COULD NOT BE REMOVED FROM THE MICROCATHETER DUE TO THE EXTENSIVE DAMAGE NOTED TO THE MICROCATHETER. IT IS PROBABLE THAT THE DEVICE WAS DAMAGED DURING THE CLINICAL PROCEDURE CAUSING THE DIFFICULTY FOR THE FLOW DIVERTER TO OPEN. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED AND ANALYZED DEFECTS AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DFU BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IMPLANTING A FLOW DIVERTER STENT (SUBJECT DEVICE) FOR AN ANEURYSM AT THE HE THE PARACLINOID SEGMENT, THE PHYSICIAN REACHED THE MI SEGMENT OF THE MCA (MIDDLE CEREBRAL ARTERY) AND TRIED TO DEPLOY THE FLOW DIVERTER STENT TWICE UNSUCCESSFULLY BUT THE STRAIGHT SEGMENT THE STENT DID NOT EXPAND AND THE SUBJECT DEVICE WAS RESHEATHED. DURING THE 2ND TRY, THE PHYSICIAN CHANGED THE WAY OF DEPLOYMENT, PUSHING THE WIRE, INSTEAD OF A PULL BACK MANEUVER BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN TRIED TO RESHEATH THE STENT BUT THE STENT WAS LOCKED INTO THE CATHETER AND PARTIALLY DEPLOYED. THE PHYSICIAN RESHEATHED EVERYTHING INSIDE AN INTERMEDIATE CATHETER, GETTING OUT FROM THE PATIENT A DISTAL ACCESS CATHETER, A MICROCATHETER (STRYKER DEVICE) AND THE SUBJECT FLOW DIVERTER STENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    THE NEUROVASCULAR STRYKER SURPASS EVOLVE DEVICE IS NOT CURRENTLY APPROVED OR COMMERCIALLY SOLD IN THE USA. THE EVENT FOR THE SURPASS EVOLVE DEVICE WAS FILED TO FDA AS A SIMILAR PRODUCT TO STRYKER DEVICE SURPASS STREAMLINE DEVICE THAT IS COMMERCIALLY AVAILABLE IN THE US (PMA # P170024). SEE SECTION 4.11.3 GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF, NOVEMBER 8, 2016. SUBJECT DEVICE NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANTING A FLOW DIVERTER STENT (SUBJECT DEVICE) FOR AN ANEURYSM AT THE HE THE PARACLINOID SEGMENT, THE PHYSICIAN REACHED THE MI SEGMENT OF THE MCA (MIDDLE CEREBRAL ARTERY) AND TRIED TO DEPLOY THE FLOW DIVERTER STENT TWICE UNSUCCESSFULLY BUT THE STRAIGHT SEGMENT THE STENT DID NOT EXPAND AND THE SUBJECT DEVICE WAS RESHEATHED. DURING THE 2ND TRY, THE PHYSICIAN CHANGED THE WAY OF DEPLOYMENT, PUSHING THE WIRE, INSTEAD OF A PULL BACK MANEUVER BUT THE SAME ISSUE OCCURRED. THE PHYSICIAN TRIED TO RESHEATH THE STENT BUT THE STENT WAS LOCKED INTO THE CATHETER AND PARTIALLY DEPLOYED. THE PHYSICIAN RESHEATHED EVERYTHING INSIDE AN INTERMEDIATE CATHETER, GETTING OUT FROM THE PATIENT A DISTAL ACCESS CATHETER, A MICROCATHETER (STRYKER DEVICE) AND THE SUBJECT FLOW DIVERTER STENT. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373929 UNKNOWN_NEUROVASCULAR_PRODUCT INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 21361398

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR EXCELSIOR XT27 MICROCATHETER (STRYKER)