MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS45015
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/30/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the procedure, the proximal of the subject flow diverter did not open after deployment.The physician attempted to access the subject flow diverter to fully open it but was unsuccessful and the surgery was stopped.The following day, another surgery was performed in attempt to fully open the subject flow diverter but was unsuccessful to fully open proximally.The patient was placed on medication and is currently home.
Event or Problem Description
It was reported that during the procedure, the proximal of the subject flow diverter did not open after deployment.The physician attempted to access the subject flow diverter to fully open it but was unsuccessful and the surgery was stopped.The following day, another surgery was performed in attempt to fully open the subject flow diverter but was unsuccessful to fully open proximally.The patient was placed on medication and is currently home.
Additional Manufacturer Narrative
B2 outcomes attributed to ae - corrected d4 lot/serial no.- corrected d4 gtin - added h4 manufacturing date ¿ added d4 expiration date - added f10 / h6 health effect - impact code - corrected due to the automated manufacturing execution system (mes), there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot 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.Additional information provided by the customer did not indicate any issues noted during unpacking or set up of the device, and the device was prepared as per dfu instructions.There was no indication of a user related issue.The anatomy was tortuous ¿ type 4 genu.A microcatheter was used to advance the flow diverter.Access was through femoral.The patient received dual anti-platelet agents prior to the procedure and post procedure.The physician does not allege any malfunction of any device for this procedure.According to the physician, the stent system wouldn¿t open proximally.The flow diverter fully apposed to the vessel wall when it was deployed, except proximally.The flow diverter was deployed.The location of the flow diverter when it failed to open was proximally near the anterior genu.It is unknown what was the surgical delay length in minutes.In the physician¿s opinion the cause of the flow diverter not to open was that he may have overloaded the device too much during deployment.A balloon was not used to fully open the flow diverter because we couldn¿t re-access the device due to tortuosity.Tuesday the physician tried to re-access the device but was unsuccessful.The patient was brought back down wednesday, and the device was opened more.Per the physician no medical intervention was necessary.There was no clinical consequence to the patient due to the reported event.The patient was kept on a heparin drip overnight- thursday the patient was sent home on aspirin and plavix (standard practice).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 as reported issue ¿stent failed/unable to open¿.

• Brand Name: SURPASS EVOLVE 4.5MM X 15MM - 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: 19391669
• Report Number: 3008881809-2024-00229
• Device Sequence Number: 18085658
• Product Code: OUT
• UDI-Device Identifier: 07613327375244
• UDI-Public: 07613327375244
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 07/03/2024

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: 09/13/2025
• Device Catalogue Number: FDS45015
• Device Lot Number: 23897393
• 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: 04/30/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/15/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: XT-27 CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female