MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK UNKNOWN (SURPASS STREAMLINE) INTRACRANIAL ANEURYSM FLOW DIVERTER

Catalog Number FD40020

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

Patient Problems Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

The subject device remains implanted.

Event Description

It was reported that the patient presented to the hospital for an elective procedure for aneurysm located in the internal carotid artery (ica). The patient had severely tortuous anatomy. A stent was used to straight the microcatheter and then the subject flow diverter was deployed successfully. On the final angiography run, it was noticed that the distal vessel had a slow flow. A computed tomography (ct) scan was performed but the images were not clear. Integrilin was administered; however, on the angiography run it was noticed that there was a subarachnoid hemorrhage (sah) in the distal vasculature. The physician applied a little glue to treat the ruptured vessel. No other information was provided.

• Brand Name: UNKNOWN (SURPASS STREAMLINE)
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 8745594
• MDR Text Key: 149554995
• Report Number: 3008881809-2019-00187
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: P170024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Expiration Date: 03/24/2020
• Device Catalogue Number: FD40020
• Device Lot Number: 21323883
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 11/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 06/28/2019 Patient Sequence Number: 1