MAUDE Adverse Event Report: SURPASS EVOLVE 3.25MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS32515
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Fistula (1862); Paresis (1998); Vascular Dissection (3160)
Date of Event	07/21/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that a stent (subject device) was implanted successfully during a procedure at pcom to opthalmic region.The patient was reported to have moderately tortuous anatomy.During a two day follow up, it was noted that the subject stent had dissected the vessel at ica causing fistula.It was also reported that the patient had weakness and small stroke.As per the physician, the adverse events were due to the patient's anatomy and the subject stent performed as intended during the procedure.The patient¿s current condition is reported to be stable and is being monitored with follow up visits.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.Additional information provided by the customer indicated that the issue occurred in the ica, the anatomy was moderately tortuous, the stent was implanted in the pcom to ophthalmic, and there were no complications/issues during the procedure of stent implantation that could have resulted in the reported event.It was also noted that the device performed as intended and the physician did not allege any malfunction for the subject stent.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.
Event or Problem Description
It was reported that a stent (subject device) was implanted successfully during a procedure at pcom to opthalmic region.The patient was reported to have moderately tortuous anatomy.During a two day follow up, it was noted that the subject stent had dissected the vessel at ica causing fistula.It was also reported that the patient had weakness and small stroke.As pet the physician, the adverse events were due to the patient's anatomy and the subject stent performed as intended during the procedure.The patient¿s current condition is reported to be stable and is being monitored with follow up visits.No other clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 3.25MM X 15MM - PMAS
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• MDR Report Key: 12329151
• Report Number: 3008881809-2021-00339
• Device Sequence Number: 4541893
• Product Code: OUT
• UDI-Device Identifier: 07613327375152
• UDI-Public: 07613327375152
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/03/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/22/2023
• Device Model Number: FDS32515
• Device Catalogue Number: FDS32515
• Device Lot Number: 22241034
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/23/2021
• Supplement Date Received by Manufacturer: 10/19/2021
• Initial Report FDA Received Date: 08/16/2021
• Supplement Report FDA Received Date: 11/03/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/23/2020
• 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