MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS32512
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
On may 18th, during the procedure, the flow diverter (subject device) was successfully implanted into the right p1 segment.It was reported that a day later, the patient had stroke symptoms.Upon doing a diagnostic, it was noticed that the flow diverter (subject device) had drifted one to two centimeter away from where it was implanted.On the 19th, a second surgery was done to correct it and successfully completed.No other information was provided.
Event or Problem Description
On (b)(6), during the procedure, the flow diverter (subject device) was successfully implanted into the right p1 segment.It was reported that a day later, the patient had stroke symptoms.Upon doing a diagnostic, it was noticed that the flow diverter (subject device) had drifted one to two centimeter away from where it was implanted.On the 19th, a second surgery was done to correct it and successfully completed.No other information was provided.
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 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.It was reported that the patient had stroke symptoms 24 hours post procedure and it was noticed that the stent had drifted 1-2cm away from where it was implanted.A second procedure was done to correct it.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 and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

• Brand Name: SURPASS EVOLVE 3.25MM X 12MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11970983
• Report Number: 3008881809-2021-00238
• Device Sequence Number: 4414901
• Product Code: OUT
• UDI-Device Identifier: 07613327385625
• UDI-Public: 07613327385625
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 09/16/2021

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 Model Number: FDS32512
• Device Catalogue Number: FDS32512
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2021
• Supplement Date Received by Manufacturer: 08/29/2021
• Initial Report FDA Received Date: 06/09/2021
• Supplement Report FDA Received Date: 09/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN MANUFACTURER)
• Outcome Attributed to Adverse Event: Other; Required Intervention