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

Catalog Number UNK_NEU

Device Problems Break (1069); Activation Failure (3270)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2019

Event Type  malfunction  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that the patient underwent flow diverter( subject device) placement in the internal carotid artery (ica) left distal (close from t bifurcation).After first deployment, position was not optimal at the distal part, re-sheathing and redeployment was need several time with an active pushing between distal portion and median portion at the bride aneurysm neck level.After a good distal position, the surpass-evolve could not open at the median level.The anatomy was very severely tortuous.The physicians retrieve the stent system and observed that the stent was constrained, did not open at the median level, and some stent wires were broken.Similar flow diverters were used to complete the procedure.There was a 2 hours surgical delay due to the anatomy that does not allow to place a flow diverter ideally.There were no clinical consequences to the patient.

Manufacturer Narrative

The neurovascular stryker surpass evolve device is not currently not approved or commercially sold in the usa.The event for the surpass evolve device was filed to fda as a similar product to stryker device surpass streamline device that is commercially available in the us (b)(4) see section 4.11.3 guidance for industry and food and drug administration staff, (b)(6) 2016.

Event Description

It was reported that the patient underwent flow diverter(subject device) placement in the internal carotid artery (ica) left distal (close from t bifurcation).After first deployment, position was not optimal at the distal part, re-sheathing and redeployment was need several time with an active pushing between distal portion and median portion at the bride aneurysm neck level.After a good distal position, the surpass-evolve could not open at the median level.The anatomy was very severely tortuous.The physicians retrieve the stent system and observed that the stent was constrained, did not open at the median level, and some stent wires were broken.Similar flow diverters were used to complete the procedure.There was a 2 hours surgical delay due to the anatomy that does not allow to place a flow diverter ideally.There were no clinical consequences to the patient.

Manufacturer Narrative

The device history record confirms that the device met all material, assembly and performance specifications.Only the stent was returned.Visual inspection was performed on the returned device and it was observed that the flow diverter stent was deformed.Functional test could not be performed as only the stent was returned.The reported stent break was not confirmed; however the event was confirmed based on the damage noted to the device.As per the additional information, the patient¿s anatomy was severely tortuous.It is probable that the severe tortuosity of the patient¿s anatomy caused the stent to become damaged during the difficult advancement through the microcatheter and causing the subsequent failure to open the stent.An assignable cause of procedural factors will be assigned to the issues of difficulty engaging target vessel and failure to open.An assignable cause of not confirmed will be assigned to the reported stent break.

Event Description

It was reported that the patient underwent flow diverter(subject device) placement in the internal carotid artery (ica) left distal (close from t bifurcation).After first deployment, position was not optimal at the distal part, re-sheathing and redeployment was need several time with an active pushing between distal portion and median portion at the bride aneurysm neck level.After a good distal position, the surpass-evolve could not open at the median level.The anatomy was very severely tortuous.The physicians retrieve the stent system and observed that the stent was constrained, did not open at the median level, and some stent wires were broken.Similar flow diverters were used to complete the procedure.There was a 2 hours surgical delay due to the anatomy that does not allow to place a flow diverter ideally.There were no clinical consequences to the patient.

• 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
• MDR Report Key: 8862607
• MDR Text Key: 158869705
• Report Number: 3008881809-2019-00228
• 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,Followup
• Report Date: 12/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/08/2020
• Device Catalogue Number: UNK_NEU
• Device Lot Number: 21443550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/05/2019
• Supplement Dates Manufacturer Received: 09/24/2019; 11/25/2019
• Supplement Dates FDA Received: 09/25/2019; 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: XT-27 MICROCATHETER (STRYKER)
• Patient Age: 73 YR