MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STENT DELIVERY SYSTEM 4MMX40MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	M003SFD040400
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Codes	Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)
Date of Event	04/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device is not available; therefore, functional testing as well as physical analysis cannot be performed.As per the additional information, the angioplasty was required- due to the surpass stent malposition.It cannot be determined if the stroke and patient complications were caused as a result of the flow diverter failure to open.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to the reported stent failed to open.An assignable cause of anticipated procedural complication will be assigned to the reported patient complications and patient stroke, 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 labelling and/or risk documentation files.This is 2 of 2 reports.The subject device remained inside patient.
Event or Problem Description
It was reported that the patient was treated with a stent flow diverter (subject device).The subject stent was implanted over the opthalmic artery but it did not oppose the parent vessel wall completely.Angioplasty was performed due to the stent malposition.6 hours post procedure, the patient developed an eye stroke and the patient vision is now cloudy.According to the physician, the eye stroke and patient¿s cloudy vision were caused by using the balloon to angioplasty to stent (subject device).No further information is available.

• Brand Name: SURPASS STENT DELIVERY SYSTEM 4MMX40MM
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8889390
• Report Number: 3008881809-2019-00239
• Device Sequence Number: 19586056
• Product Code: OUT
• UDI-Device Identifier: 07613252648802
• UDI-Public: 07613252648802
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2019

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2019
• Device Catalogue Number: M003SFD040400
• Device Lot Number: 21049975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/31/2019
• Initial Report FDA Received Date: 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention