MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 5.0MM X 40MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FDS50040

Device Problems Difficult to Remove (1528); Difficult or Delayed Activation (2577)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/07/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the procedure the physician faced resistance while advancing the subject flow diverting stent through the micro catheter and faced difficulty to re capture the subject stent into the micro catheter after partial deployment.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during the procedure the physician faced resistance while advancing the subject flow diverting stent through the micro catheter and faced difficulty to re capture the subject stent into the micro catheter after partial deployment.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9/h3 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned within a micro catheter.The reported lot number was not confirmed as the packaging was not returned with the device.On visual inspection, the stent delivery wire was protruding from the distal tip of micro catheter.The micro catheter shaft was inspected and sections were found to be stretched/rippled 10.8cm to 29.5cm from the distal end.The stent was advanced through the distal end of the micro catheter.Procedural fluids were removed from the stent.The flow diverter stent was inspected.The distal end was buckled and crushed with wires protruding.The proximal end was crushed, bent with frayed wires.On functional testing, friction was experienced advancing and retracting the stent delivery wire due to procedural fluids.The micro catheter was soaked in luke warm water and the stent was advanced without issue.The reported event is covered in the device directions for use (dfu).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.Additional information provided by the customer indicated that the device was prepared as per the dfu, continuous flush was maintained and the patient¿s anatomy was tortuous.Extreme friction was experienced advancing the stent delivery system through the micro catheter.2 attempts were made to recapture the stent back into the micro catheter, there was an allegation against the micro catheter that is had stretched/ovalized.The procedure was completed successfully and there was no medical intervention.The micro catheter shaft was stretched/rippled from the distal end to the middle which would have contributed to the extreme friction experienced advancing the device through micro catheter and subsequent recapturing the device back into the micro catheter shaft.There was severe deformation noted at both ends of the stent which most likely occurred as a result of attempting to advance and recapture the stent back into the deformed micro catheter shaft.An assignable cause of procedural factors will be assigned to the reported stent difficult/unable to advance or pull back through micro catheter, flow diverter stent difficult/unable to re-capture into micro catheter, stent partial deployment and analyzed stent difficult/unable to advance or pull back through micro catheter¿, stent deformed and stent failed/unable to open (when not implanted) as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.

• Brand Name: SURPASS EVOLVE 5.0MM X 40MM - PMAS
• Type of Device: INTRACRANIAL ANEURYSM FLOW DIVERTER
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11118605
• MDR Text Key: 225553981
• Report Number: 3008881809-2021-00007
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 07613327375329
• UDI-Public: 07613327375329
• Combination Product (y/n): N
• PMA/PMN Number: P170024/S003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Model Number: FDS50040
• Device Catalogue Number: FDS50040
• Device Lot Number: 22422897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2021
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XT -27 MICROCATHETER (STRYKER)
• Patient Age: 73 YR