MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 20MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FDS50020

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

Patient Problem Dysphasia (2195)

Event Date 08/21/2021

Event Type  Injury  

Manufacturer Narrative

1 of 5 reports.Device is implanted in patient.

Event Description

It was reported in a clinical trial that a procedure was done to treat a right internal carotid artery-ophthalmic (c6 segment) intracranial aneurysm with flow diversion.The procedure was completed with successful implantation of the subject flow diverter and complete coverage of the target aneurysm with no device deficiencies noted.The next day post procedure, the patient had some expressive aphasia.This was reported to be resolving spontaneously but caused the patient frustration and anxiety.This event was reported by the site as related to the subject flow diverter, catheter, guide wire, micro catheter and balloon catheter.

Event Description

It was reported in a clinical trial that a procedure was done to treat a right internal carotid artery-ophthalmic (c6 segment) intracranial aneurysm with flow diversion.The procedure was completed with successful implantation of the subject flow diverter and complete coverage of the target aneurysm with no device deficiencies noted.The next day post procedure, the patient had some expressive aphasia.This was reported to be resolving spontaneously but caused the patient frustration and anxiety.This event was reported by the site as related to the subject flow diverter, catheter, guide wire, micro catheter and balloon catheter.

Manufacturer Narrative

D4: expiration date - added.H4: manufacturing date ¿ added.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.It was reported that post procedure the patient feels that they have had some expressive aphasia after the procedure.They state that it is still present and getting better with time, but can cause frustration and anxiety.The procedure was completed successfully and without delay.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 as reported 'patient neurological deficit' for this complaint.

• Brand Name: SURPASS EVOLVE 5.0MM X 20MM - PMAS
• 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: 13641328
• MDR Text Key: 286657379
• Report Number: 3008881809-2022-00090
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2023
• Device Catalogue Number: FDS50020
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2020
• 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: AXS CATALYST 5 0.058IN X 115CM (STRYKER).; EXCELSIOR XT-27 (STRYKER).; SYNCHRO SELECT 0.014IN X 215CM (STRYKER).; TRANSFORM BALLOON (STRYKER).
• Patient Outcome(s): Other
• Patient Age: 38 YR
• Patient Sex: Female
• Patient Weight: 91 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White