MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 30MM - IDE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FDC40030

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

Patient Problems Stroke/CVA (1770); Thromboembolism (2654); Speech Disorder (4415)

Event Date 09/28/2022

Event Type  Injury  

Event Description

It was reported that one day post procedure for left posterior communicating artery with the subject flow diverter, the patient had aphasia adjudicated as a minor stroke ischemic ipsilateral.Mri revealed multiple signs of recent ischemic stroke in the frontal and left parieto-occipital region, in connection with thromboembolic accidents per procedure.There was no device deficiency reported.The study device was implanted successfully, completely covering the neck in conjunction with a previously implanted device (coiling was performed in (b)(6) 2022).According to site this adverse event is not related to the subject flow diverter but according to cec members it had a causal relationship with the procedure and a possible relationship with the subject flow diverting stent and dapt (dual anti-platelet therapy).The adverse event was resolved without any treatment.No additional information available.

Manufacturer Narrative

H3 other text : the device remains implanted in the patient.

Event Description

It was reported that one day post procedure for left posterior communicating artery with the subject flow diverter, the patient had aphasia adjudicated as a minor stroke ischemic ipsilateral.Mri revealed multiple signs of recent ischemic stroke in the frontal and left parieto-occipital region, in connection with thromboembolic accidents per procedure.There was no device deficiency reported.The study device was implanted successfully, completely covering the neck in conjunction with a previously implanted device (coiling was performed in (b)(6) 2022).According to site this adverse event is not related to the subject flow diverter but according to cec members it had a causal relationship with the procedure and a possible relationship with the subject flow diverting stent and dapt (dual anti-platelet therapy).The adverse event was resolved without any treatment.No additional information available.

Manufacturer Narrative

H4 manufacturing date ¿ added, d4 expiration date - added, d4 lot # - corrected from 22312218 to 22312218r.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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 was no medical intervention.The surgery start time: 8:04; end time: 11h16.The patient¿s mrs score=0.There was no device deficiency reported.The study device was implanted successfully, completely covering the neck in conjunction with a previously implanted device (coiling was performed in (b)(6) 2022).The site reported the adverse event as not related to the study device but the cec (clinical events committee) members considered the adverse event was possibly related to the study device.An assignable cause of anticipated procedural complication will be assigned to the reported event 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.

• Brand Name: SURPASS EVOLVE 4.0MM X 30MM - IDE
• 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: 17123389
• MDR Text Key: 317113359
• Report Number: 3008881809-2023-00299
• 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: 08/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2023
• Device Catalogue Number: FDC40030
• Device Lot Number: 22312218R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/08/2020
• 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
• Treatment: 7 RX COIL KA (NON-STRYKER)
• Patient Outcome(s): Other
• Patient Age: 43 YR
• Patient Sex: Male