MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 30MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS50030
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Codes	Paresis (1998); Visual Impairment (2138)
Date of Event	05/30/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device remains implanted in the patient.
Event or Problem Description
It was reported that the there was ¿fish mouthed¿ on the proximal end of the subject stent.Patients right side shut down and not doing great.No additional information available.
Additional Manufacturer Narrative
B5 executive summary - updated.F10 / h6 clinical signs code grid - health effect - clinical code - updated.F10 / h6 health impact code grid - health effect - impact code - updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; 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).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 reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.There were adverse consequences to the patient ¿patients right side shut down and not doing great- does not have more info on the impact/ patient's status follow up with (b)(6)¿.Received on 30-apr-2024: patient has some deficit (vision).An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient neurological deficit¿ 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 with the directions for use, product labeling and/or risk documentation files.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned to the reported issue ¿stent tapering¿.
Event or Problem Description
It was reported that the there was ¿fish mouthed¿ on the proximal end of the subject stent.Patients right side shut down and not doing great.No additional information available.Update: received additional information on 30-apr-2024 stated the anatomical location of the reported issue was right proximal petrous segnment and the patient has some deficit (vision).In the physician¿s opinion it is considered as a neurologic deficit and the adverse event is related to the reported issue of 80% fish mouthing of proximal stent.There was no hyperplasia or thrombosis.No additional information available.

• Brand Name: SURPASS EVOLVE 5.0MM X 30MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 19067153
• Report Number: 3008881809-2024-00154
• Device Sequence Number: 17816480
• Product Code: OUT
• UDI-Device Identifier: 07613327375312
• UDI-Public: 07613327375312
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/12/2023
• Device Catalogue Number: FDS50030
• Device Lot Number: 22590529
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/26/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 04/08/2024
• Supplement Report FDA Received Date: 05/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown