MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK SURPASS EVOLVE 4.0MM X 12MM - PMAS; INTRACRANIAL ANEURYSM FLOW DIVERTER

Model Number FDS40012

Device Problem Activation Failure (3270)

Patient Problem Stenosis (2263)

Event Date 06/24/2021

Event Type  Injury  

Manufacturer Narrative

Device is implanted in patient.

Event Description

It was reported that during a procedure in the left internal carotid artery, the proximal segment of the subject flow diverter was unable to open after deployment.Femoral access was used in moderately tortuous anatomy.The physician reported no resistance during delivery of the subject flow diverter.Any surgical delay that may have occurred during the procedure was unknown.A balloon was unable to be used to open the proximal segment of the subject flow diverter as access to the target location was lost.Sluggish flow was noted in the patients vessel due to proximal closing of the subject flow diverter.The physician administered anti coagulant medication to prevent/breakup any clot that may/might/or already formed as a result of the closed subject flow diverter.The patient was reported to have been taken to the intensive care unit.No other information is present.

Manufacturer Narrative

Due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 from the complaint indicated that no anomalies were noted to the flow diverter delivery system prior to use, the device was prepared as per the dfu, continuous flush was maintained, femoral access was used for the procedure, the tortuosity of the patient's anatomy was moderate, an xt-27 microcatheter was used with the subject device, the position of the flow diverter implant was confirmed between the two marker bands, the flow diverter failed to open proximally in the left ica, and there was no resistance upon delivery but resistance of the stent wanting to open proximally was noted.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable will be assigned to this complaint.

Event Description

It was reported that during a procedure in the left internal carotid artery, the proximal segment of the subject flow diverter was unable to open after deployment.Femoral access was used in moderately tortuous anatomy.The physician reported no resistance during delivery of the subject flow diverter.Any surgical delay that may have occurred during the procedure was unknown.A balloon was unable to be used to open the proximal segment of the subject flow diverter as access to the target location was lost.Sluggish flow was noted in the patients vessel due to proximal closing of the subject flow diverter.The physician administered anti coagulant medication to prevent/breakup any clot that may/might/or already formed as a result of the closed subject flow diverter.The patient was reported to have been taken to the intensive care unit.No other information is present.

• Brand Name: SURPASS EVOLVE 4.0MM X 12MM - 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: 12194214
• MDR Text Key: 262410647
• Report Number: 3008881809-2021-00304
• Device Sequence Number: 1
• Product Code: OUT
• UDI-Device Identifier: 07613327386516
• UDI-Public: 07613327386516
• 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: 10/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/06/2023
• Device Model Number: FDS40012
• Device Catalogue Number: FDS40012
• Device Lot Number: 22387941
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/24/2021
• Initial Date FDA Received: 07/19/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 10/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EXCELSIOR XT-27 MICRO CATHETER (STRYKER).; EXCELSIOR XT-27 MICRO CATHETER (STRYKER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 74 YR