MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS40020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hyperplasia (1906)
Date of Event	05/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that 8 months post implant of the subject stent in the internal carotid artery, the physician is concerned about the non flow limiting hyperplasia in the vessel.There are no neurological deficit in the patient.No other information is available.
Additional Manufacturer Narrative
The device is implanted in the patient.
Event or Problem Description
It was reported that 8 months post implant of the subject stent in the internal carotid artery, the physician is concerned about the non flow limiting hyperplasia in the vessel.There are no neurological deficit in the patient.No other information is available.
Additional Manufacturer Narrative
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, visual testing as well as functional 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 indicated that the implantation date for the subject stent was approximately 8 months prior to complaint submission date.The lot # of subject surpass evolve is unknown.The subject stent surpass evolve was successfully implanted in the ica.The changes observed in the size or shape of the aneurysm during follow-up was that the aneurysm was still filling.The physician is not satisfied with the performance of the subject stent surpass evolve device at follow-up.The patient¿s anatomy was average tortuous.The patient¿s current condition has no neurological deficit and there were no neurological deficits related to the reported event.There was no reported mechanical injury to artery at the location of the hyperplasia.There were no difficulties encountered during procedure that could have contributed to the reported event.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.H3 other text: the device is implanted in the patient.

• Brand Name: SURPASS EVOLVE 4.0MM X 20MM - 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: 14498619
• Report Number: 3008881809-2022-00245
• Device Sequence Number: 17537537
• Product Code: OUT
• UDI-Device Identifier: 07613327375206
• UDI-Public: 07613327375206
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/18/2022

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?: No
• Operator of Device: Health Professional
• Device Model Number: FDS40020
• Device Catalogue Number: FDS40020
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/03/2022
• Supplement Date Received by Manufacturer: 07/25/2022
• Initial Report FDA Received Date: 05/25/2022
• Supplement Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown