BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURPASS EVOLVE 4.5MM X 30MM - CE

    MDR report key: 16613190 · Received March 24, 2023

    Report

    Report Number
    3008881809-2023-00153
    Event Type
    Death
    Date Received
    March 24, 2023
    Date of Event
    March 9, 2023
    Report Date
    March 24, 2023
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024/S003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE RESULTS OF THE DEVICE HISTORY RECORD (DHR) REVIEW, THERE IS NO INDICATION THAT THE DEVICE, LABELLING OR PACKAGING FAILED TO MEET ITS SPECIFICATIONS WHEN RELEASED. THE SUBJECT STENT DEVICE WAS NOT RETURNED TO SITE FOR PRODUCT ANALYSIS AS THE SUBJECT STENT WAS IMPLANTED; THEREFORE, A VISUAL INSPECTION AS WELL AS A FUNCTIONAL EVALUATION COULD NOT BE PERFORMED. THE REPORTED EVENT IS COVERED IN THE DEVICE DIRECTIONS FOR USE (DFU). IT WAS REPORTED THAT AN INFINITY AND MIDDLE CATHETER WERE USED TO BUILD ACCESS AND A SYNCHRO GUIDEWIRE WAS USED TO BRING THE XT-27 MICROCATHETER AND SL-10 MICROCATHETER TO THE LOCATION. THEN A 4.5*30 EVOLVE STENT (SUBJECT DEVICE) AND DELIVERED IT THROUGH XT-27 MICROCATHETER TO DEPLOY SUCCESSFULLY AND FILLED TWO 20*50 COILS (VISEE) THROUGH SL-10 MICROCATHETER TO FINISH THE PROCEDURE. THERE WAS TWO NON- STRYKER 20*50 COILS (VISEE) IMPLANTED IN THE ANEURYSM, WHICH MAY HAVE CONTRIBUTED TO THE DELAYED ANEURYSM RUPTURE. THE SUBJECT STENT DEVICE SHOULD ONLY BE USED BY PHYSICIANS WHO HAVE RECEIVED APPROPRIATE TRAINING IN INTERVENTIONAL NEURORADIOLOGY OR INTERVENTIONAL RADIOLOGY AND PRECLINICAL TRAINING ON THE USE OF THESE DEVICES AS ESTABLISHED BY STRYKER NEUROVASCULAR. THE PATIENT EXPERIENCED VISION BLURRED AND GIDDINESS OF LEFT EYE WITHOUT NOTABLE INCENTIVE MORE THAN 2 MONTHS AGO. THE PATIENT HAD A HISTORY OF HYPERTENSION FOR 5 YEARS, WITH THE MAXIMUM BLOOD PRESSURE (BP) OF 145/90 MMHG, AND HAD RECEIVED ORAL NIFEDIPINE SUSTAINED-RELEASE TABLETS, WITH BP STABLY CONTROLLED. DURING THE ADMITTANCE PROCESS THE DIAGNOSIS WAS AS FOLLOWS: ANEURYSM WITH THROMBOSIS IN THE INTERNAL SEGMENT OF LEFT INTERNAL CAROTID ARTERY; CYTOGENIC BRAIN EDEMA [CYTOTOXIC BRAIN EDEMA]; VASOGENIC BRAIN EDEMA; HYPERTENSION GRADE 3 (VERY HIGHLY RISKY). THE EVENT DESCRIPTION AND ADDITIONAL INFORMATION DOES NOT INDICATE A DEVICE ISSUE AND THIS IS AN ANTICIPATED OUTCOME. AS A PRODUCT RELATED ROOT CAUSE DOES NOT APPLY AND THE ISSUE IS DUE TO A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND/OR PATIENT CONDITION NOTED WITHIN THE DFU, AN ASSIGNABLE CAUSE OF ANTICIPATED PROCEDURAL COMPLICATION WILL BE ASSIGNED TO THE REPORTED 'PATIENT ANEURYSM RUPTURE, PATIENT DEATH, PATIENT HEMORRHAGE, BLOOD LOSS WITH SEQUELAE, PATIENT NEUROLOGICAL DEFICIT AND PATIENT COMPLICATIONS.'

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT UNDERWENT SUCCESSFUL ENDOVASCULAR SURPASS EVOLVE FLOW-DIVERTER (SUBJECT STENT) ASSISTED COILING EMBOLIZATION PROCEDURE FOR ICA (INTERNAL CAROTID ARTERY) C6 (CLINOID SEGMENT) ANEURYSM SIZED 15MMX14MMX14MM. OTHER STRYKER DEVICES (INFINITY CATALYST, SYNCHRO GUIDEWIRE, XT-27 MICROCATHETER, AND SL-10 MICROCATHETER) WERE USED IN THE PROCEDURE IN CONJUNCTION WITH THE SUBJECT STENT DEVICE. AFTER ONE DAY POST PROCEDURE, THE PATIENT HAD ANEURYSM RUPTURED, SUBARACHNOID HEMORRHAGE, CONVULSION, VOMITING OF GASTRIC CONTENTS AND DISTURBANCE OF CONSCIOUSNESS AND THE PATIENT ALSO DEVELOPED DISEASE PROGRESS AGGRAVATED AND LEFT MYDRIASIS. MEDICAL INTERVENTION WAS PERFORMED WITH CRANIOTOMY MICROSCOPIC ISOLATION OF ANEURYSM AT TERMINAL OF LEFT INTERNAL CAROTID ARTERY + HEMATOMA REMOVAL + DECOMPRESSIVE CRANIECTOMY + VENTRICULAR DRILLING FOR DRAINAGE WERE PERFORMED IN EMERGENCY DEPARTMENT UNDER GENERAL ANESTHESIA. POST MEDICAL INTERVENTION HYPOTENSION WAS DEVELOPED. SECOND DAY POST PROCEDURE, THE PATIENT HAD CARDIAC ARREST. RESCUE ACTIONS WERE IMPLEMENTED IMMEDIATELY, INCLUDING CHEST COMPRESSION, VENTILATOR-ASSISTED VENTILATION, AND REPEATED EPINEPHRINE IV BOLUS, BUT THE CARDIAC BEATS AND RESPIRATION DID NOT RECOVER, AND THE ELECTROCARDIOGRAM SHOWED TOTAL CARDIAC ARREST. THE PATIENT WAS DECLARED CLINICALLY DEAD. THE RELATIONSHIP BETWEEN STRYKER DEVICE AND ADVERSE EVENTS (ANEURYSM RUPTURED, SUBARACHNOID HEMORRHAGE, AND DEATH OF THE PATIENT) IS UNKNOWN AT THIS TIME. PER MEDICAL RECORD, THE ANEURYSM RUPTURED OF TERMINAL OF LEFT INTERNAL CAROTID ARTERY AND SUBARACHNOID HEMORRHAGE; BRAIN HERNIA; AND CENTRAL RESPIRATORY FAILURE WERE CAUSED OF DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375282 SURPASS EVOLVE 4.5MM X 30MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 23999049R

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Female Death| R| H| O COILS (VISSE)| INFINITY CATALYST (STRYKER)| SL-10 MICROCATHETER (STRYKER)| SYNCHRO GUIDEWIRE (STRYKER)| XT-27 MICROCATHETER (STRYKER)