MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 17MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45017
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
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 during post processing with synchro wire the proximal stent (subject device) moved and obstructed flow.Which caused a surgical delay.The patient was discharged on brilinta and aspirin.The patient's condition is stable.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during post processing with synchro wire the proximal stent (subject device) moved and obstructed flow.Which caused a surgical delay.The patient was discharged on brilinta and aspirin.The patient's condition is stable.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.It was reported that during post processing with a synchro select 014 wire, the proximal stent (subject device) moved and obstructed flow.Additional information provided by the customer indicated that the device was confirmed to be in good condition prior to use and was prepared as per the dfu, continuous flush was maintained throughout the procedure, the tortuosity of the patient's anatomy was moderate, an xt-27 microcatheter was used with the subject device, there was no allegation against the microcatheter, no resistance was encountered when advancing the surpass evolve system through the microcatheter, the size of the stent was appropriate for the treatment site, and the position of the stent was confirmed under fluoroscopy.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 and the device was not returned, an assignable cause of undeterminable was assigned to this complaint.

• Brand Name: SURPASS EVOLVE 4.5MM 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: 12858892
• Report Number: 3008881809-2021-00484
• Device Sequence Number: 4352848
• Product Code: OUT
• UDI-Device Identifier: 07613327386639
• UDI-Public: 07613327386639
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 02/25/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/22/2024
• Device Model Number: FDS45017
• Device Catalogue Number: FDS45017
• Device Lot Number: 22810404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/15/2021
• Supplement Date Received by Manufacturer: 02/10/2022
• Initial Report FDA Received Date: 11/23/2021
• Supplement Report FDA Received Date: 02/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2021
• 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: SL 10 MICROCATHETER (STRYKER MANUFACTURER); SYNCHRO SELECT 014 (STRYKER MANUFACTURER); XT 27 MICROCATHETER (STRYKER MANUFACTURER)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female