MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.5MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number	FDS45012
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2022
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 the procedure, the stent (subject device) did not open on the proximal end after deployment.The physician used snare devices to retrieve the subject stent out of the patient's anatomy.After several attempts, the physician was able to snare the device and move it proximally to a less concerning location in the vasculature.The subject stent couldn't be retrieved entirely from the patient's vasculatures as it got stuck in a turn.A stent was deployed across the unopened subject stent to prevent it from free-floating in the patient's anatomy and push it to the less concerning location in the vasculature.Additional medication was administered to the patient due to this event.No 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, functional testing as well as visual testing 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.Additional information provided indicates the stent did not open on the proximal end after deployment.It was not removed from the patient after several attempts using a 4mm snare device along with a 6mm stent retriever device, but was left in the internal carotid artery due to getting stuck in a turn, and was tacked down with a stent.The patient is in good condition with no deficits.The patient was loaded with brelinta the morning of the procedure and was also taking aspirin.Prus were taken prior to the procedure.The patient was put on an overnight heparin drip after the procedure.The overnight heparin drip was not originally planned.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, a cause of undeterminable was assigned to the reported ¿stent failed/unable to open¿ and "un-retrieved device fragments".
Event or Problem Description
It was reported that during the procedure, the stent (subject device) did not open on the proximal end after deployment.The physician used snare devices to retrieve the subject stent out of the patient's anatomy.After several attempts, the physician was able to snare the device and move it proximally to a less concerning location in the vasculature.The subject stent couldn't be retrieved entirely from the patient's vasculatures as it got stuck in a turn.A stent was deployed across the unopened subject stent to prevent it from free-floating in the patient's anatomy and push it to the less concerning location in the vasculature.Additional medication was administered to the patient due to this event.No clinical consequences were reported to the patient due to this event.

• Brand Name: SURPASS EVOLVE 4.5MM X 12MM - 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: 14432834
• Report Number: 3008881809-2022-00233
• Device Sequence Number: 14753134
• Product Code: OUT
• UDI-Device Identifier: 07613327386592
• UDI-Public: 07613327386592
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/12/2022

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: 02/24/2024
• Device Model Number: FDS45012
• Device Catalogue Number: FDS45012
• Device Lot Number: 22767506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2022
• Supplement Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/25/2021
• 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: AXS CATALYST 5 DISTAL ACCESS CATHETER (STRYKER); BMX LONG SHEATH (PENUMBRA); EXCELSIOR XT-27 MICROCATHETER (STRYKER); GOOSENECK SNARE DEVICE (MEDTRONIC); SOLITAIRE STENT RETRIEVER (MEDTRONIC)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown