MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	08/03/2022
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 in the cavernous segment of the internal carotid artery on (b)(6) 2021.Nine months post procedure during routine follow-up angiogram was performed which reveled hundred percent stenosis of the patient's internal carotid artery and the subject flow diverter stent.There was no blood flow distal to the stenosis.It was reported that the patient was asymptomatic.It was reported that the subject flow diverter stent performed as intended during deployment.According to the physician the stenosis of the parent vessel artery is due to in subject stent stenosis, but patient did have atherosclerosis in the parent vessel artery.It was noted that there was parent vessel stenosis prior to treatment on the proximal end of the aneurysm.No more information is available.
Event or Problem Description
It was reported that the subject flow diverter stent was implanted in the cavernous segment of the internal carotid artery on (b)(6)2021.Nine months post procedure during routine follow-up angiogram was performed which reveled hundred percent stenosis of the patient's internal carotid artery and the subject flow diverter stent.There was no blood flow distal to the stenosis.It was reported that the patient was asymptomatic.It was reported that the subject flow diverter stent performed as intended during deployment.According to the physician the stenosis of the parent vessel artery is due to in subject stent stenosis, but patient did have atherosclerosis in the parent vessel artery.It was noted that there was parent vessel stenosis prior to treatment on the proximal end of the aneurysm.No more information is available.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the lot number remains unknown, 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 provided by the customer indicated there were no anomalies noted to the device prior to use and the device was prepared as per the dfu.The devices performed as intended during deployment.There were no difficulties encountered during the procedure that could have contributed to reported issue.In the physician¿s opinion, the stenosis was related to the subject device.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 the reported 'patient parent vessel stenosis¿ for this complaint.

• Brand Name: SURPASS EVOLVE 4.5MM 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: 15318565
• Report Number: 3008881809-2022-00419
• Device Sequence Number: 5467116
• Product Code: OUT
• UDI-Device Identifier: 07613327375282
• UDI-Public: 07613327375282
• 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): 11/21/2022

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: FDS45040
• Device Catalogue Number: FDS45040
• 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: 08/04/2022
• Supplement Date Received by Manufacturer: 10/28/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 11/21/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: AXS INFINITY LS LONG SHEATH (STRYKER); CAT 5 INTERMEDIATE CATHETER ( STRYKER); EXCELSIOR XT-27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Age: 56 YR
• Patient Sex: Male