MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 25MM - CE; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD50025

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

Patient Problems Stroke/CVA (1770); Thrombosis (2100)

Event Date 06/15/2020

Event Type  Injury  

Manufacturer Narrative

This is the second of 2 reports.The subject device remains implanted in the patient.

Event Description

It was reported that the subject flow diverter was used to treat a large fusiform aneurysm of the right cavernous internal carotid artery (ica).Procedure was completed with two flow diverters and nine coils.Angiography showed treatment to be effective.Procedure time was recorded as 4 hours 45 minutes.In recovery, patient was found to have dense left-sided hemiparesis and was taken back to angiography for thrombectomy immediately.In angiography, a thrombus was found to be at the distal end of subject flow diverter (supraclinoid segment of ica).Physician was unable to access thrombus for mechanical thrombectomy or aspiration.However, intra-arterial anticoagulants were administered to break down thrombus.The next morning, patient was orientated, communicating verbally and displayed equal power in upper and lower limbs bilaterally.No other information is available.

Manufacturer Narrative

Due to the automated mes 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.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, an assignable cause of anticipated procedural complication will be assigned to the reported patient stroke and patient vessel thrombosis.

Event Description

It was reported that the subject flow diverter was used to treat a large fusiform aneurysm of the right cavernous internal carotid artery (ica).Procedure was completed with two flow diverters and nine coils.Angiography showed treatment to be effective.Procedure time was recorded as 4 hours 45 minutes.In recovery, patient was found to have dense left-sided hemiparesis and was taken back to angiography for thrombectomy immediately.In angiography, a thrombus was found to be at the distal end of subject flow diverter (supraclinoid segment of ica).Physician was unable to access thrombus for mechanical thrombectomy or aspiration.However, intra-arterial anticoagulants were administered to break down thrombus.The next morning, patient was orientated, communicating verbally, and displayed equal power in upper and lower limbs bilaterally.No other information is available.

• Brand Name: SURPASS EVOLVE 5.0MM X 25MM - CE
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10258760
• MDR Text Key: 198376115
• Report Number: 3008881809-2020-00201
• 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
• Report Date: 08/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/27/2020
• Device Catalogue Number: FD50025
• Device Lot Number: 21895605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 9 TARGET COILS (STRYKER); SURPASS FLOW DIVERTER (STRYKER); 9 TARGET COILS (STRYKER); SURPASS FLOW DIVERTER (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 48 YR