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

Catalog Number	FDS45017
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Stenosis (2263)
Date of Event	06/30/2023
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 6 months post internal carotid artery (ica) aneurysm embolization procedure, the stent (subject device) migrated on the distal end.Narrowing of the luminal diameter vessel wall led to the tapering of the flow diverter at the end.Neointimal hyperplasia observed and the percentage of stenosis was 51-75%.The patient is on anti-platelet medication.No other information is available.
Additional Manufacturer Narrative
C2 / d10 concomitant products grid: updated 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 provided by the customer indicated there were no anomalies noted to the subject stent prior to use, the device was prepared as per dfu, continuous flush was maintained, the catheter tip was not shaped, there was no resistance encountered during navigation of the subject stent device to the target lesion, the position of the delivery catheter was confirmed by visualizing the radiopaque markers, there was no resistance encountered during the flow diverter deployment, the position of the subject stent implant was confirmed between the two marker bands, the subject stent was confirmed to be fully deployed under fluoroscopy during the procedure, there was no injury/resistance encountered during the procedure.Clarification was received regarding what was meant by the stent became narrow - narrowing of the vessel luminal diameter due to changes in the vessel wall which leads to tapering of the flow diverter at the end.There were no changes observed in the size or shape of the aneurysm during follow-up, aneurysm still filling.The percentage stenosis present pre procedure was 0-25% - none.The percentage stenosis present post procedure was 76-100%.There was neointimal hyperplasia observed at the 6 month follow up and the percentage stenosis at the 6 month follow up was 51-75%.There was no medical intervention done to cater for the stenosis if present, but concerned they will need to if it continues to worsen.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 dislodged/migrated.An assignable cause of anticipated procedural complication will be assigned to the reported event of stenosis with stent deformation, 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.
Event or Problem Description
It was reported that 6 months post internal carotid artery (ica) aneurysm embolization procedure, the stent (subject device) migrated on the distal end.Narrowing of the luminal diameter vessel wall led to the tapering of the flow diverter at the end.Neointimal hyperplasia observed and the percentage of stenosis was 51-75%.The patient is on anti-platelet medication.No other information is available.

• 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: 17395862
• Report Number: 3008881809-2023-00379
• Device Sequence Number: 5955287
• Product Code: OUT
• UDI-Device Identifier: 07613327386639
• UDI-Public: 07613327386639
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/12/2023

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 Catalogue Number: FDS45017
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/30/2023
• Supplement Date Received by Manufacturer: 08/30/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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 CATHETER (STRYKER); CATALYST 5 CATHETER (STRYKER); SYNCHRO SELECT SOFT GUIDEWIRE (STRYKER); SYNCHRO SELECT SOFT GUIDEWIRE (STRYKER); XT-27 MICROCATHETER (STRYKER); XT-27 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male