BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SURPASS EVOLVE 4.0MM X 20MM - CE

    MDR report key: 9665344 · Received February 4, 2020

    Report

    Report Number
    3008881809-2020-00029
    Event Type
    Malfunction
    Date Received
    February 4, 2020
    Date of Event
    January 18, 2020
    Report Date
    April 3, 2020
    Manufacturer
    STRYKER NEUROVASCULAR CORK
    Product Code
    OUT
    PMA / PMN Number
    P170024
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    B1: ADVERSE EVENT/PRODUCT PROBLEM: NOT APPLICABLE H1: TYPE OF REPORTABLE EVENT: NOT APPLICABLE DUE TO THE AUTOMATED MES 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. NO ANOMALIES WERE NOTED TO THE DEVICE PRIOR TO THE PROCEDURE AND THE DFU WAS FOLLOWED DURING THE PREPARATION OF THE DEVICE. AS PER THE EVENT DESCRIPTION, 'PHYSICIAN STARTED TO UNSHEATH EVOLVE BELOW PCOM BUT THE DISTAL END DID NOT OPEN COMPLETELY EVEN AFTER DEPLOYING 25%. AFTER RESHEATHING THE DEVICE, IT DID OPEN AT THE BENT AFTER SEVERAL MANEUVERING AND RESHEATHING ATTEMPTS. '. AS THE DEVICE WAS NOT RETURNED TO SITE FOR ANALYSIS, AN ASSIGNABLE CAUSE OF 'UNDETERMINABLE' WILL BE ASSIGNED TO THE REPORTED DEFECTS. NON-REPORTABLE RATIONALE: BASED ON FURTHER REVIEW, THE REPORTED EVENT DESCRIPTION, THE SUBJECT FLOW DIVERTER FAILED TO OPEN BUT WAS RECAPTURED BY THE OPERATOR AND SUCCESSFULLY REMOVED FROM THE PATIENT¿S BODY. THE PHYSICIAN DID NOT TAKE ANY ACTION/ INTERVENTION DUE TO THIS EVENT. THERE WAS NO REPORTED PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE, NO MEDICAL OR SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OF A BODY FUNCTION OR STRUCTURE WAS PERFORMED AND THE EVENT WAS NOT LIFE THREATENING. THERE WAS NO INFORMATION TO REASONABLY SUGGEST THAT THIS TYPE OF MALFUNCTION WOULD LIKELY CAUSE OR CONTRIBUTE TO A DEATH OR SERIOUS INJURY IF THE MALFUNCTION WERE TO REOCCUR. THE MANUFACTURER HAS REVIEWED ALL INFORMATION AND DETERMINED THIS EVENT NO LONGER MEETS THE REQUIREMENT OF THE REPORTABLE EVENT FOR THE SUBJECT DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) ATTEMPTED TO BE DEPLOYED BELOW POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM WITH THE DISTAL ARTERY MEASURED AROUND 3.6MM AND PROXIMAL AROUND 4.1MM, THE DISTAL END OF THE STENT (SUBJECT DEVICE) DID NOT OPEN COMPLETELY EVEN AFTER DEPLOYING (B)(4). AFTER RE SHEATHING THE SUBJECT DEVICE, IT DID OPEN AT THE BENT AFTER SEVERAL MANEUVERING AND RESHEATHING ATTEMPTS. THE STENT (SUBJECT DEVICE) WAS FINALLY TAKEN OUT ALONG WITH MICROCATHETER AND THE STENT (SUBJECT DEVICE) WAS DEPLOYED COMPLETELY INSIDE SALINE BOWL WHICH HALF OF THE STENT (SUBJECT DEVICE) WAS OPENED AND ANOTHER HALF WAS COMPRESSED COMPLETELY. FINALLY, THE PHYSICIAN REPLACED IT WITH A NEW ATLAS STENT AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE PHYSICIAN PLANS TO PUT A BRAIDED STENT INSIDE THE NEW ALAS STENT AFTER FEW WEEKS.

    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. THE SUBJECT DEVICE IS UNAVAILABLE TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) ATTEMPTED TO BE DEPLOYED BELOW POSTERIOR COMMUNICATING ARTERY (PCOM) ANEURYSM WITH THE DISTAL ARTERY MEASURED AROUND 3.6MM AND PROXIMAL AROUND 4.1MM, THE DISTAL END OF THE STENT (SUBJECT DEVICE) DID NOT OPEN COMPLETELY EVEN AFTER DEPLOYING 25%. AFTER RE SHEATHING THE SUBJECT DEVICE, IT DID OPEN AT THE BENT AFTER SEVERAL MANEUVERING AND RESHEATHING ATTEMPTS. THE STENT (SUBJECT DEVICE) WAS FINALLY TAKEN OUT ALONG WITH MICROCATHETER AND THE STENT (SUBJECT DEVICE) WAS DEPLOYED COMPLETELY INSIDE SALINE BOWL WHICH HALF OF THE STENT (SUBJECT DEVICE) WAS OPENED AND ANOTHER HALF WAS COMPRESSED COMPLETELY. FINALLY, THE PHYSICIAN REPLACED IT WITH A NEW ATLAS STENT AND COMPLETED THE PROCEDURE WITHOUT CLINICAL CONSEQUENCES TO THE PATIENT. THE PHYSICIAN PLANS TO PUT A BRAIDED STENT INSIDE THE NEW ALAS STENT AFTER FEW WEEKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126619 SURPASS EVOLVE 4.0MM X 20MM - CE INTRACRANIAL ANEURYSM FLOW DIVERTER OUT STRYKER NEUROVASCULAR CORK 21723075

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR EXCELSIOR XT 27 MICROCATHETER (STRYKER)| NEURON 053 (NON STRYKER)| NEURON MAX (NON STRYKER)