MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	FDS40017
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device remains in the patient.
Event or Problem Description
It was reported that during the procedure, the stent (subject device) was placed inside of a left ica vessel.Upon full deployment the proximal end of the stent (subject device) failed to adequately open fully and appose to the vessel wall.The physician attempted to open the proximal of the subject stent with guidewire manipulation and a balloon but was unsuccessful.A second stent was deployed to adequately open the proximal end of the first stent (subject device).There was a surgical delay of 2-3 hours.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during the procedure, the stent (subject device) was placed inside of a left ica vessel.Upon full deployment the proximal end of the stent (subject device) failed to adequately open fully and appose to the vessel wall.The physician attempted to open the proximal of the subject stent with guidewire manipulation and a balloon but was unsuccessful.A second stent was deployed to adequately open the proximal end of the first stent (subject device).There was a surgical delay of 2-3 hours.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
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 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 states the flow diverter system was placed inside of a left ica vessel in a routine flow diverting procedure.Upon full deployment of the flow diverter the proximal end failed to adequately open fully and oppose the vessel wall.A flow diverter stent was deployed to adequately open the proximal end of the first flow diverter which led to surgical delay of 2-3 hours.It is most likely procedural or anatomical factors encountered during the process contributed to the reported event but this cannot be confirmed as the device was not returned for analysis.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, an assignable cause of undeterminable was assigned to the as reported event of the stent failed/unable to open.

• Brand Name: SURPASS EVOLVE 4.0MM X 17MM - 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: 17486956
• Report Number: 3008881809-2023-00405
• Device Sequence Number: 20801357
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170024/S003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2024
• Device Catalogue Number: FDS40017
• Device Lot Number: 22964266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2023
• Supplement Date Received by Manufacturer: 08/22/2023
• Initial Report FDA Received Date: 08/09/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2021
• 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: GUIDE CATHETER (UNKNOWN); GUIDEWIRE (UNKNOWN); SCEPTER BALLOON (MICROVENTION); SURPASS EVOLVE STENT (STRYKER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female