MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS ELITE FDS 5.0MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDSE50040
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the aneurysm procedure in the vertebrobasilar artery the subject flow diverter experienced twisting/kinking following deployment.A catheter was used to open the pinch point as a medical intervention.The subject flow diverter did fully appose against the vessel walls at the end of the procedure.Balloon angioplasty was used post subject stent deployment.There was no impact to the patient as a result of the event.
Event or Problem Description
It was reported that during the aneurysm procedure in the vertebrobasilar artery the subject flow diverter experienced twisting/kinking following deployment.A catheter was used to open the pinch point as a medical intervention.The subject flow diverter did fully appose against the vessel walls at the end of the procedure.Balloon angioplasty was used post subject stent deployment.There was no impact to the patient as a result of the event.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis 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.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 event of stent deformed and stent improperly deployed.

• Brand Name: SURPASS ELITE FDS 5.0MM X 40MM - 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: 20438791
• Report Number: 3008881809-2024-00475
• Device Sequence Number: 8183853
• Product Code: OUT
• UDI-Device Identifier: 07613327583151
• UDI-Public: (01)07613327583151(17)270612(10)24995661
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• 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): 12/09/2024

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 Catalogue Number: FDSE50040
• Device Lot Number: 24995661
• 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: 09/20/2024
• Supplement Date Received by Manufacturer: 11/18/2024
• Initial Report FDA Received Date: 10/14/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: AXS CATALYST 5 CATHETER (STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER); NEUROFORM ATLAS STENT (STRYKER); SYNCHRO SELECT STANDARD (STRYKER); TRANSFORM 7 X 10 BALLOON (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown