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

Catalog Number FD45017

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

Patient Problems Paresis (1998); Dysphasia (2195); Convulsion/Seizure (4406); Ischemia Stroke (4418)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

Device is implanted in patient.

Event Description

It was reported that in a clinical trial, a procedure was performed in the left carotid-ophthalmic artery for recanalization of a previously ruptured brain aneurysm.During the procedure, the first flow diverter was released spontaneously into the microcatheter during the re-sheathing maneuvers at the level of the carotid siphon.This caused a 20 minute procedure delay to replace with the subject flow diverter.Patient was reported to have suffered a stroke during the procedure with probable relationship to the subject device and possible relationship to dual anti-platelet medication which may have been insufficient.Patient was treated with medication and event resolved with motor deficit of the upper right limb predominant in hand.Event was also reported to have been complicated by generalized epilepsy but it is unknown if patient had a pre-existing seizure disorder, or this was secondary to the study procedure.Ischemic lesions were observed on the mri performed 24 hours after the procedure.No other information is available.

Event Description

It was reported that in a clinical trial, a procedure was performed in the left carotid-ophthalmic artery for recanalization of a previously ruptured brain aneurysm.During the procedure, the first flow diverter was released spontaneously into the microcatheter during the re-sheathing maneuvers at the level of the carotid siphon.This caused a 20 minute procedure delay to replace with the subject flow diverter.Patient was reported to have suffered a stroke during the procedure with probable relationship to the subject device and possible relationship to dual anti-platelet medication which may have been insufficient.Patient was treated with medication and event resolved with motor deficit of the upper right limb predominant in hand.Event was also reported to have been complicated by generalized epilepsy but it is unknown if patient had a pre-existing seizure disorder, or this was secondary to the study procedure.Ischemic lesions were observed on the mri performed 24 hours after the procedure.No other information is available.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.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.Additional information provided by the customer indicated that the patient was being treated for recanalization of a previously ruptured brain aneurysm, the subject flow diverter spontaneously released in the microcatheter during re sheathing maneuvers at the level of the carotid siphon.Based upon medical review, the harm observed in this complaint is anticipated in nature as per the device risk assessment.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 within the dfu, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.

• Brand Name: SURPASS EVOLVE 4.5MM X 17MM - CE
• Type of Device: 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: 12708811
• MDR Text Key: 278808355
• Report Number: 3008881809-2021-00452
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2020
• Device Catalogue Number: FD45017
• Device Lot Number: 21785987
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Disability; Required Intervention; Other
• Patient Age: 44 YR
• Patient Sex: Female