MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 17MM - PMAS INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FDS40017

Device Problem Migration (4003)

Patient Problems Intracranial Hemorrhage (1891); Paralysis (1997); Paresis (1998); Perforation of Vessels (2135); Brain Injury (2219); Loss of consciousness (2418)

Event Date 12/20/2021

Event Type  Injury  

Event Description

It was reported that during the treatment of a micro perforation at m2 of left mca, physician used the microcatheter and guidewires to deploy the subject flow diverting stent. He re -sheathed the subject stent and during deployment it was slightly migrated to forward direction while applying forward pressure to delivery system and covered the mca branch. 15 minutes post deployment physician noticed contrast leaking distal to the subject stent indicating vessel perforation. On review of imaging, it was cleared that the perforation happened before subject stent deployment and after the placement of microcatheter and guidewires. It is undeterminable if the devices caused the perforation. Balloon angioplasty was performed to stop bleeding and protamine was administered to reverse heparin. 4 hours post procedure patient started bleeding again at m1/m2 bifurcation. Another surgery was performed to remove the blood from brain and the subject stent was seen protruding from the vessel. It is undeterminable if the subject stent caused the perforation. Patient suffered paralysis and is currently in icu. No additional information available.

Manufacturer Narrative

One of the four mdrs. The device is not available to the manufacturer.

• Brand Name: SURPASS EVOLVE 4.0MM X 17MM - PMAS
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 13310701
• MDR Text Key: 284150390
• Report Number: 3008881809-2022-00027
• Device Sequence Number: 1
• Product Code: OUT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P170024/S003
• 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: 05/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: FDS40017
• Device Catalogue Number: FDS40017
• Device Lot Number: 22451788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 01/20/2022 Patient Sequence Number: 1

Treatment

AXS INFINITY LONG SHEATH (STRYKER); AXS VECTA INTERMEDIATE CATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR XT27 MICROCATHETER (STRYKER); SELECT CATHETER (PENUMBRA); SYNCHRO 10 GUIDEWIRE (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); TRANSFORM BALLOON CATHETER (STRYKER)