BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN (SURPASS STREAMLINE)

    MDR report key: 9200020 · Received October 16, 2019

    Report

    Report Number
    3008881809-2019-00313
    Event Type
    Injury
    Date Received
    October 16, 2019
    Date of Event
    October 7, 2019
    Report Date
    December 19, 2019
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT LONG DESCRIPTION: UNKNOWN (SURPASS STREAMLINE). CATALOG#: UNKNOWN. LOT/SERIAL NO.: UNKNOWN. THE DEVICE HISTORY RECORD (DHR) REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. DURING VISUAL INSPECTION, ONLY THE STENT DELIVERY WIRE (SDW) WAS RETURNED. THERE WAS SOME SLIGHT BENDING NOTED TO THE DISTAL SECTION OF THE STENT DELIVERY. NO OTHER ANOMALIES WERE NOTED. A FUNCTIONAL TEST COULD NOT BE PERFORMED AS THE STENT DELIVERY WIRE WAS ONLY RETURNED AND THE FLOW DIVERTER HAD BEEN DEPLOYED. AS PER THE AVAILABLE INFORMATION, THE PATIENT¿S ICA WAS A REGULAR ONE, WITH THE CURVES CLOSE TO THE ANEURYSM VERY TIGHT. ONLY THE SDW OF THE DEVICE WAS RETURNED AS THE FLOW DIVERTER HAD BEEN DEPLOYED. THE SDW WAS NOTED TO BE KINKED. IT IS PROBABLE THAT THE DEVICE WAS DAMAGED AS A RESULT OF ADVANCING THROUGH THE PATIENT¿S ANATOMY CAUSING THE REPORTED EVENT. AN ASSIGNABLE CAUSE OF PROCEDURAL FACTORS WILL BE ASSIGNED TO THE REPORTED AND ANALYZED EVENTS AS THE ISSUE IS ASSOCIATED WITH A PRODUCT THAT MEETS STRYKER DESIGN AND MANUFACTURE SPECIFICATIONS AND WAS USED IN ACCORDING WITH THE DIRECTIONS FOR USE BUT DUE TO PROCEDURAL AND/OR ANATOMICAL FACTORS DURING USE, THE PRODUCT PERFORMANCE WAS LIMITED. THE NEUROVASCULAR STRYKER SURPASS EVOLVE DEVICE IS NOT CURRENTLY NOT 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT FLOW DIVERTER WAS ADVANCED THROUGH THE MICRO CATHETER TO THE TARGET VESSEL. THE FLOW DIVERTER WAS DEPLOYED IN THE FIRST PORTION OF THE PATIENT VESSEL AND AT A CERTAIN POINT NEAR THE CAROTID OPHTHALMIC CURVE, IT WAS UNABLE TO OPEN. THE PHYSICIAN PERFORMED A PUSH AND PULL MANEUVER AND RE-SHEATHED THE DEVICE THREE TIMES. AFTER THE LAST MANEUVER, THE PHYSICIAN NOTICED THAT THE STENT WAS NOT HELD ANYMORE BY THE RESHEATHING PAD. THEREFORE THE PHYSICIAN DECIDED TO COMPLETE DEPLOYMENT BY PULLING BACK THE MICRO CATHETER AND THE STENT OPENED WELL PROXIMALLY BUT IN THE CURVE IT WAS NOT WELL APPOSED SO THE PHYSICIAN USED A BALLOON IN ORDER TO POST DILATE. AFTER DILATION THE STENT WAS SHORTENED MORE DISTALLY THAN PROXIMALLY, LEAVING A PORTION OF THE ANEURYSM NECK UNCOVERED. SO THE PHYSICIAN DECIDED TO DEPLOY A SECOND DEVICE IN ORDER TO BETTER COVER THE ANEURYSM NECK AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Additional Manufacturer Narrative · 1

    SUBJECT DEVICE IS NOT AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE SUBJECT FLOW DIVERTER WAS ADVANCED THROUGH THE MICRO CATHETER TO THE TARGET VESSEL. THE FLOW DIVERTER WAS DEPLOYED IN THE FIRST PORTION OF THE PATIENT VESSEL AND AT A CERTAIN POINT NEAR THE CAROTID OPHTHALMIC CURVE, IT WAS UNABLE TO OPEN. THE PHYSICIAN PERFORMED A PUSH AND PULL MANEUVER AND RE-SHEATHED THE DEVICE THREE TIMES. AFTER THE LAST MANEUVER, THE PHYSICIAN NOTICED THAT THE STENT WAS NOT HELD ANYMORE BY THE RESHEATHING PAD. THEREFORE THE PHYSICIAN DECIDED TO COMPLETE DEPLOYMENT BY PULLING BACK THE MICRO CATHETER AND THE STENT OPENED WELL PROXIMALLY BUT IN THE CURVE IT WAS NOT WELL APPOSED SO THE PHYSICIAN USED A BALLOON IN ORDER TO POST DILATE. AFTER DILATION THE STENT WAS SHORTENED MORE DISTALLY THAN PROXIMALLY, LEAVING A PORTION OF THE ANEURYSM NECK UNCOVERED. SO THE PHYSICIAN DECIDED TO DEPLOY A SECOND DEVICE IN ORDER TO BETTER COVER THE ANEURYSM NECK AND CONTINUED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    990715 UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention EXCELSIOR XT-27 MICRO CATHETER (STRYKER)