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

Catalog Number M003SFD040200

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

Patient Problems Hemorrhage, Cerebral (1889); Intracranial Hemorrhage (1891)

Event Date 09/15/2019

Event Type  Injury  

Manufacturer Narrative

This is the first of 2 reports.Subject device remains implanted.

Event 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.

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 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
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9142826
• MDR Text Key: 161676298
• Report Number: 3008881809-2019-00295
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 07613252648734
• UDI-Public: 07613252648734
• Combination Product (y/n): N
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2019
• Device Catalogue Number: M003SFD040200
• Device Lot Number: 20938982
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/15/2019
• Initial Date FDA Received: 10/01/2019
• Supplement Dates Manufacturer Received: 11/07/2019
• Supplement Dates FDA Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR