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

Model Number	FDS40017
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Codes	Stroke/CVA (1770); Stenosis (2263)
Date of Event	09/16/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is implanted inside the patient's vasculature.
Event or Problem Description
It was reported that a neurovascular procedure was performed in a patient for stent implantation on (b)(6) 2022.On six month follow-up it was noted that proximal end of subject flow diverter stent had migrated distally and appears to be larger at the neck of the aneurysm.The subject stent showed stenosis, more worse on the proximal end and both the proximal and distal ends of the subject flow diverter stent are fish mouthed.The percentage of stenosis is unknown.The patient is reported to have had two strokes due to the reported issue and the patient is on dapt (dual antiplatelet therapy) which is extended indefinitely.No additional information is available.
Event or Problem Description
It was reported that a neurovascular procedure was performed in a patient for stent implantation on (b)(6) 2022.On six month follow-up it was noted that proximal end of subject flow diverter stent had migrated distally and appears to be larger at the neck of the aneurysm.The subject stent showed stenosis, more worse on the proximal end and both the proximal and distal ends of the subject flow diverter stent are fish mouthed.The percentage of stenosis is unknown.The patient is reported to have had two strokes due to the reported issue and the patient is on dapt (dual antiplatelet therapy) which is extended indefinitely.No additional information is available.
Additional Manufacturer Narrative
Although the dhr could not be reviewed because the lot number remains unknown, 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.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, that the stent performed as intended during the procedure, the physician did not allege any malfunction of any device for this procedure.The indication of the medical procedure was to treat aneurysm.The anatomical location of the target lesion was the right paraopthalmic , the anatomical site where the stent migrated to from the target lesion was that the proximal end of device migrated distally and appears to be larger at the neck of the aneurysm.Proximal ends are fishmouthed.There were adverse consequences/ neurological sequel to the patient due to the reported stent migration as patient had two strokes.The patient was put on dapt indefinitely.It was clarified by the customer that, both proximal and distal end of the stent had fishmouthed, however, the proximal end appears to be worse.There were vessel wall/intimal changes noted at the site of implantation.Stenosis was noted inside device but the percentage of stenosis was not specified.Changes in the aneurysm were that the aneurysm is occluded.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 issue ¿stent dislodged/migrated¿.An assignable cause of anticipated procedural complication will be assigned to the reported "patient stroke¿ and ¿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.Based upon medical review, the harm observed in the complaint is anticipated in nature as per the device risk assessment.

• 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: 15577372
• Report Number: 3008881809-2022-00501
• Device Sequence Number: 15293445
• Product Code: OUT
• UDI-Device Identifier: 07613327386530
• UDI-Public: 07613327386530
• 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
• Device Implanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2022

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 Model Number: FDS40017
• Device Catalogue Number: FDS40017
• 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: 09/16/2022
• Supplement Date Received by Manufacturer: 11/22/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 12/13/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Age: 60 YR
• Patient Sex: Female