MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS STENT DELIVERY SYSTEM 4MMX20MM; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number	M003SFD040200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)
Date of Event	08/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device remains implanted.
Event or Problem Description
It was reported that approximately 1 month and half post stenting of a flow diverter (subject device), the patient suffered a stroke with right-sided hemiparesis and dysphasia that requiring percutaneous endoscopic gastrostomy (peg) tube.According to the physician, the reason for the stroke was that the perforators were coming out of the aneurysm dome in the middle cerebral artery m1 segment.It is understood that the subject device implantation contributed to the blockage of the perforator leading to stroke.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported event could not be confirmed; however, the reported patient stroke and patient complications of neurological deficits a known risks associated with endovascular procedures and noted as such in the device directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported that approximately 1 month and half post stenting of a flow diverter (subject device), the patient suffered a stroke with right-sided hemiparesis and dysphasia that requiring percutaneous endoscopic gastrostomy (peg) tube.According to the physician, the reason for the stroke was that the perforators were coming out of the aneurysm dome in the middle cerebral artery m1 segment.It is understood that the subject device implantation contributed to the blockage of the perforator leading to stroke.

• Brand Name: SURPASS STENT DELIVERY SYSTEM 4MMX20MM
• Common Device Name: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8985752
• Report Number: 3008881809-2019-00264
• Device Sequence Number: 19616249
• Product Code: OUT
• UDI-Device Identifier: 07613252648734
• UDI-Public: 07613252648734
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P170024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2019

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: 01/08/2020
• Device Catalogue Number: M003SFD040200
• Device Lot Number: 21130975
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/28/2019
• Supplement Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 09/10/2019
• Supplement Report FDA Received Date: 10/21/2019
• 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
• Patient Age: 67 YR