MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45017
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Stroke/CVA (1770); Dysphasia (2195)
Date of Event	05/18/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
A stent (subject device) was successfully deployed and implanted within the patient on (b)(6) 2021.Later the same evening, the patient was found to have stroke-like symptoms and presented with aphasia.The development of stroke-like symptoms and aphasia was reported to be related to the subject stent.A cta showed that the proximal end of the subject stent implant had partially closed off.It was reported that the proximal end of the subject stent likely was not fully opposed to the vessel wall which resulted in its gradual closing.After administering a medication (integrilin) the patient's symptoms had resolved and the patient was transported to the interventional lab for further evaluation.The subject stent was discovered on angiogram to have opened more than what was presented on the cta, but with a ledge still remaining.A new stent was placed within the proximal end of the subject stent to allow it to open.The remainder of the subject stent was fully intact and well opposed.Patients symptoms resolved after medication administration.No other clinical consequences were reported to the patient due to this event.
Event or Problem Description
A stent (subject device) was successfully deployed and implanted within the patient on (b)(6) 2021.Later the same evening, the patient was found to have stroke-like symptoms and presented with aphasia.The development of stroke-like symptoms and aphasia was reported to be related to the subject stent.A cta showed that the proximal end of the subject stent implant had partially closed off.It was reported that the proximal end of the subject stent likely was not fully opposed to the vessel wall which resulted in its gradual closing.After administering a medication (integrilin) the patient's symptoms had resolved and the patient was transported to the interventional lab for further evaluation.The subject stent was discovered on angiogram to have opened more than what was presented on the cta, but with a ledge still remaining.A new stent was placed within the proximal end of the subject stent to allow it to open.The remainder of the subject stent was fully intact and well opposed.Patients symptoms resolved after medication administration.No other clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
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, visual and functional testing as well as physical analysis cannot be performed.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.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 a flow diverting stent was implanted within the patient.Periprocedural device deployment went well.Later the same evening, the patient was found to have stroke-like symptoms and presented with aphasia.The flow diverting stent was discovered on angiogram to have opened more than what was presented on the cta, but with a ledge still remaining.A stent was placed within the proximal end of the flow diverting stent to allow it to open.The remainder of the stent was fully intact and well opposed.Patients symptoms resolved after medication was administrated.Additional information provided by the customer indicated that the device was confirmed to be in good condition before use, preparation was performed according to the instructions for use, continuous flush was maintained throughout the procedure, the tortuosity of the patient's anatomy was moderately tortuous.It is most likely that procedural or anatomical factors encountered during the procedure contributed to the event, but this cannot be conclusively determined.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 4.5MM X 17MM - 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: 11987694
• Report Number: 3008881809-2021-00246
• Device Sequence Number: 16943248
• Product Code: OUT
• UDI-Device Identifier: 07613327386639
• UDI-Public: 07613327386639
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2021

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 Expiration Date: 08/30/2023
• Device Model Number: FDS45017
• Device Catalogue Number: FDS45017
• Device Lot Number: 22422917
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/19/2021
• Supplement Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 06/11/2021
• Supplement Report FDA Received Date: 09/21/2021
• 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: NEUROFORM ATLAS STENT (STRYKER).
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 74 YR