MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS 3X20; INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number M003101FPP0

Device Problem Activation Failure (3270)

Patient Problem Thrombosis (2100)

Event Date 11/18/2019

Event Type  Injury  

Manufacturer Narrative

This is the 2 of the 2 reports.The device remains implanted in patient.

Event Description

It was reported that after approximately 18 months post stenting procedure, intra-stent thrombosis in the proximal part of the distal stent due to the bad apposition on the vessel wall was noted with high-resolution cone-beam computed tomography (vasoct).Medication of ticagrelor was administrated to the patient as a required treatment.No further information is available.

Event Description

It was reported that after approximately 18 months post stenting procedure, intra-stent thrombosis in the proximal part of the distal stent due to the bad apposition on the vessel wall was noted with high-resolution cone-beam computed tomography (vasoct).Medication of ticagrelor was administrated to the patient as a required treatment.No further information is available.

Manufacturer Narrative

D4: expiration date: added.H4: manufacturing date: added.The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The reported event is covered in the device dfu (direction for use).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The subject device stayed implanted inside the patient; therefore, physical as well as a functional evaluation could not be performed.Therefore, based on the information currently available the exact cause for the reported event cannot be determined.

• Brand Name: SURPASS 3X20
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 9536389
• MDR Text Key: 173532158
• Report Number: 3008881809-2019-00418
• Device Sequence Number: 1
• Product Code: OUT
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: M003101FPP0
• Device Lot Number: 18979888
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SURPASS 3X20 (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 60