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

Catalog Number FDC45017

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

Patient Problems Visual Impairment (2138); Cognitive Changes (2551)

Event Date 12/10/2021

Event Type  Injury  

Event Description

It was reported in a clinical trial procedure to treat a right posterior communicating artery aneurysm, the patient had hemianopia and delirium.On imaging, occipital micro embolic infarcts were seen which resulted in prolonged hospitalization for the patient.The event was treated with physiotherapy and oral olanzapin 5 mg for delirium for 5 days and recovered.In the physician's opinion, the event was possibly related to the subject device and other stryker devices used in the procedure.

Manufacturer Narrative

1 of 9 reports.Device is implanted in patient.

Manufacturer Narrative

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.Due to the automated manufacturing execution system there are controls in the manufacturing process to ensure the product met specifications upon release.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.It was reported that the patient had 'hemianopia & delirium (patient not oriented to time & place; visual impairment).The issue was treated with physiotherapy and oral olanzapin 5 mg for delirium for 5 days'.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.

Event Description

It was reported in a clinical trial procedure to treat a right posterior communicating artery aneurysm, the patient had hemianopia and delirium.On imaging, occipital micro embolic infarcts were seen which resulted in prolonged hospitalization for the patient.The event was treated with physiotherapy and oral olanzapin 5 mg for delirium for 5 days and recovered.In the physician's opinion, the event was possibly related to the subject device and other stryker devices used in the procedure.

• Brand Name: SURPASS EVOLVE 4.5MM X 17MM - 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: 13262421
• MDR Text Key: 283951556
• Report Number: 3008881809-2022-00015
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 03/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/12/2022
• Device Catalogue Number: FDC45017
• Device Lot Number: 21862563
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/22/2021
• Initial Date FDA Received: 01/15/2022
• Supplement Dates Manufacturer Received: 03/14/2022
• Supplement Dates FDA Received: 03/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2019
• 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
• Treatment: EXCELSIOR XT27 1 TIP STRAIGHT 150CM X 6CM.; SL-10 2 TIP STRAIGHT 150CM X 6CM.; SYNCHRO 0.014IN X 200CM.; SYNCHRO 0.014IN X 300CM.; TARGET 360 SOFT 5MM X 15CM.; TARGET 360 SOFT 6MM X 20CM.; TARGET 360 STANDARD 6MM X 15CM.; TARGET 360 STANDARD 7MM X 20CM.
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female