MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40015
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Stroke/CVA (1770); Paresis (1998); Speech Disorder (4415)
Date of Event	09/28/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is implanted inside the patient's vasculature.
Event or Problem Description
It was reported that the subject flow diverter stent was implanted successfully during the procedure with a minor ledge distally.Thirty minutes post procedure, the patient experienced weakness showing multiple stroke symptoms with weakness in the left side, facial droop and slurred speech prompting a return to angio suite for intervention.It was discovered that the proximal end of the subject flow diverter had collapsed.An additional surgery was performed, where the physician deployed an additional flow diverter stent to open the proximal end of the subject flow diverter stent.Patient is continuing to experience weakness and is still treated in the intensive care unit at the hospital but shows no stroke on imaging.Patient will continue on dapt and intergrelin for now.According to the physician the reported event was due to subject flow diverter stent failure on the proximal end.No further information is available.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated mes system 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 indicated there was no anomalies to the fds prior to use, the dfu was followed and continuous flush was maintained throughout the procedure.Additional information states "30 minutes into recovery patient experience weakness prompting a return to angio suite.The patient was alert and responsive initially, but began showing multiple stroke symptoms with weakness in her left side, facial droop and slurred speech in pacu.During the assessment they called code stroke for her to return to the angio suite for intervention.Physician attempted to access the collapsed stent with a micro catheter to deploy an additional flow diverter stent to open the proximal end of the stent.Patient is still in the icu at the hospital with weakness but shows no stroke on imaging.Patient will continue on dapt and intergrelin".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 failed/unable to open¿.An assignable cause of anticipated procedural complication will be assigned to the reported ¿patient stroke¿, 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 labelling and/or risk documentation files.
Event or Problem Description
It was reported that the subject flow diverter stent was implanted successfully during the procedure with a minor ledge distally.Thirty minutes post procedure, the patient experienced weakness showing multiple stroke symptoms with weakness in the left side, facial droop and slurred speech prompting a return to angio suite for intervention.It was discovered that the proximal end of the subject flow diverter had collapsed.An additional surgery was performed, where the physician deployed an additional flow diverter stent to open the proximal end of the subject flow diverter stent.Patient is continuing to experience weakness and is still treated in the intensive care unit at the hospital but shows no stroke on imaging.Patient will continue on dapt and intergrelin for now.According to the physician the reported event was due to subject flow diverter stent failure on the proximal end.No further information is available.

• Brand Name: SURPASS EVOLVE 4.0MM 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: 15638746
• Report Number: 3008881809-2022-00517
• Device Sequence Number: 14923099
• Product Code: OUT
• UDI-Device Identifier: 07613327375190
• UDI-Public: 07613327375190
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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: 08/16/2024
• Device Model Number: FDS40015
• Device Catalogue Number: FDS40015
• Device Lot Number: 23110886
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/28/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/20/2022
• Supplement Report FDA Received Date: 12/13/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/18/2021
• 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: EXCELSIOR XT-27 CATHETER (STRYKER).; SCEPTER C 4X11 BALLOON (UNKNOWN).
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Female