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	Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891)
Date of Event	09/15/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the first of 2 reports.Subject device remains implanted.
Event or Problem Description
It was reported that the patient underwent successful flow diverter (subject device) placement on the internal carotid artery (ica).An initial stent was attempted to be placed but it did not track as intended.The physician and proctor decided on a second stent (subject device) which tracked and deployed without issue.Four days post-procedure, the patient was re-admitted to the hospital for a reperfusion hemorrhage.It has not been determined if the hemorrhage was caused by the surpass or if it was caused by pharmaceutical means.No additional information is available at this time.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The reported intracranial hemorrhage is a known risk 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 the patient underwent successful flow diverter (subject device) placement on the internal carotid artery (ica).An initial stent was attempted to be placed but it did not track as intended.The physician and proctor decided on a second stent (subject device) which tracked and deployed without issue.Four days post-procedure, the patient was re-admitted to the hospital for a reperfusion hemorrhage.It has not been determined if the hemorrhage was caused by the surpass or if it was caused by pharmaceutical means.No additional information is available at this time.

• 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: 9142826
• Report Number: 3008881809-2019-00295
• Device Sequence Number: 14214588
• Product Code: OUT
• UDI-Device Identifier: 07613252648734
• UDI-Public: 07613252648734
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 12/02/2019

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: 10/08/2019
• Device Catalogue Number: M003SFD040200
• Device Lot Number: 20938982
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/15/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 10/01/2019
• Supplement Report FDA Received Date: 12/02/2019
• 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: 60 YR