MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 30MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45030
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stenosis (2263); Ischemia Stroke (4418); Embolism/Embolus (4438)
Date of Event	09/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that the subject flow diverter was deployed across the neck of the unruptured posterior communicating artery aneurysm and there was narrowing at the mid-section of the subject device following deployment.Physician determined that the patient had underlying intracranial atherosclerotic disease in this portion of the internal carotid artery.During procedure, the physician tried to treat the device narrowing using a balloon but was not successful.Patient had embolic showers and some stroke like symptoms, six hours post implantation of the subject flow diverter.Unknown medication was given to the patient.Patient condition was stable.No other information is available.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The reported event is covered in the device 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.Based upon medical review, the harm observed in the 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 with the directions for use, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.
Event or Problem Description
It was reported that the subject flow diverter was deployed across the neck of the unruptured posterior communicating artery aneurysm and there was narrowing at the mid-section of the subject device following deployment.Physician determined that the patient had underlying intracranial atherosclerotic disease in this portion of the internal carotid artery.During procedure, the physician tried to treat the device narrowing using a balloon but was not successful.Patient had embolic showers and some stroke like symptoms, six hours post implantation of the subject flow diverter.Unknown medication was given to the patient.Patient condition was stable.No other information is available.

• Brand Name: SURPASS EVOLVE 4.5MM X 30MM - 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: 10659866
• Report Number: 3008881809-2020-00296
• Device Sequence Number: 3168574
• Product Code: OUT
• UDI-Device Identifier: 07613327375275
• UDI-Public: 07613327375275
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2020

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 Expiration Date: 04/22/2023
• Device Model Number: FDS45030
• Device Catalogue Number: FDS45030
• Device Lot Number: 22240834
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2020
• Supplement Date Received by Manufacturer: 11/06/2020
• Initial Report FDA Received Date: 10/09/2020
• Supplement Report FDA Received Date: 12/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR