MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 15MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FDS50015

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

Patient Problem Stroke/CVA (1770)

Event Date 07/29/2021

Event Type  Injury  

Manufacturer Narrative

Device not returned for evaluation.

Event Description

It was reported during the procedure the patient suffered a stroke with unknown relation to the stent (subject device).The patient was placed on a ventilator and had a nih score of 18 after the event.No further information is available.

Manufacturer Narrative

The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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 mes 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 after deploying the subject stent the patient had a stroke.The patient is currently on a ventilator, nih 18 last follow up.Based upon medical review, the harm observed in the 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 with the directions for use, product labeling and/or risk documentation files, an assignable cause of anticipated procedural complication will be assigned to this complaint.H3 other text : device not returned for evaluation.

Event Description

It was reported during the procedure the patient suffered a stroke with unknown relation to the stent (subject device).The patient was placed on a ventilator and had a nih score of 18 after the event.No further information is available.

• Brand Name: SURPASS EVOLVE 5.0MM X 15MM - 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: 12366355
• MDR Text Key: 268092225
• Report Number: 3008881809-2021-00346
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 07613327386691
• UDI-Public: 07613327386691
• 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: 12/02/2021

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 Model Number: FDS50015
• Device Catalogue Number: FDS50015
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/29/2021
• Initial Date FDA Received: 08/25/2021
• Supplement Dates Manufacturer Received: 11/04/2021
• Supplement Dates FDA Received: 12/02/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 CAT 5 CATHETER (STRYKER).; AXS CAT 5 CATHETER (STRYKER)
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female