MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STENT DELIVERY SYSTEM 4MMX30MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	M003SFD040300
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Visual Disturbances (2140)
Date of Event	06/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device evaluated by mfr: the device remains in patient.
Event or Problem Description
It was reported that the subject stent was successfully implanted during the procedure; however, two days post procedure, the patient experienced vision changes.No other information was provided.
Event or Problem Description
It was reported that the subject stent was used successfully for aneurysm located in the ophthalmic artery; however, two days post procedure, the patient experienced vision changes.The patient¿s vision is improving on its own and an intraoperative milrinone was given to the patient on the follow up angiography.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, an assignable cause of anticipated procedural factor was assigned to the as reported issue patient complication, as a device related root cause does not apply and the issue is due to a known physiological effect that is noted with the direction for use (dfu), device labeling and/or risk documentation.Outcomes attributed to ae: updated to include required intervention to prevent permanent impairment/damage (devices) executive summary: corrected: intraoperative milrinone treatment was given to the patient on the follow up angiography.

• Brand Name: SURPASS STENT DELIVERY SYSTEM 4MMX30MM
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8719407
• Report Number: 3008881809-2019-00176
• Device Sequence Number: 2211612
• Product Code: OUT
• UDI-Device Identifier: 07613252648796
• UDI-Public: 07613252648796
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,Followup
• Report Date (Section B): 07/23/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 01/09/2020
• Device Catalogue Number: M003SFD040300
• Device Lot Number: 21131864
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/01/2019
• Supplement Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 07/23/2019
• 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