MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 3.25MM X 12MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD32512

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Muscle Weakness (1967); Transient Ischemic Attack (2109); Blurred Vision (2137)

Event Date 10/09/2020

Event Type  Injury  

Manufacturer Narrative

This is 1 of 5 reports.Is implanted in patient.

Event Description

It was reported in the clinical trial that one day post procedure in the internal carotid artery-ophthalmic (c6 segment), the patient developed left upper limb weakness which resolved the next day.Unknown drug treatment was administered and the event resolved.12 days post procedure, the patient also developed right eye visual blurring which resolved after fourteen days.No treatment was given for this event.202 days post procedure, the patient had a transient ischemic attack (tia) which presented with left sided numbness and weakness in the face, upper and lower limbs.The tia resolved the next day after unknown drug treatment was administered.Imaging done post tia was unremarkable.All 3 events had possible relation to the flow diverter.The left upper limb weakness had possible relation to the procedure, dual antiplatelet therapy and other stryker devices used in the procedure.The tia had possible relation to the procedure.No other information is available.

Manufacturer Narrative

This is 1 of 5 reports.

Event Description

It was reported in the clinical trial that one day post procedure in the internal carotid artery-ophthalmic (c6 segment), the patient developed left upper limb weakness which resolved the next day.Unknown drug treatment was administered and the event resolved.12 days post procedure, the patient also developed right eye visual blurring which resolved after fourteen days.No treatment was given for this event.202 days post procedure, the patient had a transient ischemic attack (tia) which presented with left sided numbness and weakness in the face, upper and lower limbs.The tia resolved the next day after unknown drug treatment was administered.Imaging done post tia was unremarkable.All 3 events had possible relation to the flow diverter.The left upper limb weakness had possible relation to the procedure, dual antiplatelet therapy and other stryker devices used in the procedure.The tia had possible relation to the procedure.No other information is available.Additional information received from the site on 01-june-2021 updated the adverse event term left upper limb weakness to transient ischemic attack.

Event Description

It was reported in the clinical trial that one day post procedure in the internal carotid artery-ophthalmic (c6 segment), the patient developed left upper limb weakness which resolved the next day.Unknown drug treatment was administered and the event resolved.12 days post procedure, the patient also developed right eye visual blurring which resolved after fourteen days.No treatment was given for this event.202 days post procedure, the patient had a transient ischemic attack (tia) which presented with left sided numbness and weakness in the face, upper and lower limbs.The tia resolved the next day after unknown drug treatment was administered.Imaging done post tia was unremarkable.All 3 events had possible relation to the flow diverter.The left upper limb weakness had possible relation to the procedure, dual antiplatelet therapy and other stryker devices used in the procedure.The tia had possible relation to the procedure.No other information is available.Additional information received from the site on 01-june-2021 updated the adverse event term left upper limb weakness to transient ischemic attack.

Manufacturer Narrative

This is 1 of 5 reports.Based on the results of the edhr (electronic device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The reported complaint 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.The event details states "the patient had a transient ischemic attack that resolved the next day and required treatment".The reported patient complications and tia (transient ischemic attack), are known and anticipated complications to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, a probable cause of anticipated procedural complication was assigned to this event.

• Brand Name: SURPASS EVOLVE 3.25MM X 12MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11873657
• MDR Text Key: 252426388
• Report Number: 3008881809-2021-00213
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2021
• Device Catalogue Number: FD32512
• Device Lot Number: 22165335
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AXS CATALYST 5 (STRYKER); EXCELSIOR XT-27 (STRYKER); STRYKER INFINITY 088 LS 6F/90CM; STRYKER SYNCOR SOFT 2 0.014X200CM
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 50 YR