MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 17MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD32517

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stenosis (2263)

Event Date 05/07/2021

Event Type  Injury  

Manufacturer Narrative

Device is implanted in patient.

Event Description

It was reported in the clinical trial that 4 months post procedure in the posterior communicating artery, the patient experienced distal stenosis of the subject stent within the carotid t, which was visible on arteriography but did not impact blood flow.The event was reported as ongoing and no treatment was administered due to this event.No other information is available.

Event Description

It was reported in the clinical trial that 4 months post procedure in the posterior communicating artery, the patient experienced distal stenosis of the subject stent within the carotid t, which was visible on arteriography but did not impact blood flow.The event was reported as ongoing and no treatment was administered due to this event.No other information is available.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.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 is probable that the anatomy of the patient contributed to the reported event, but this cannot be conclusively determined.An assignable cause of anticipated procedural complication will be assigned to the reported patient parent vessel stenosis 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 labeling and/or risk documentation files.

• Brand Name: SURPASS EVOLVE 3.25MM X 17MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11967629
• MDR Text Key: 255158774
• Report Number: 3008881809-2021-00235
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2022
• Device Catalogue Number: FD32517
• Device Lot Number: 21620427
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 56 YR