MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK AXS CATALYST 5 - 058X115 (FDA); CATHETER, PERCUTANEOUS

Catalog Number M003IC0581150

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

Patient Problems Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)

Event Date 08/20/2019

Event Type  Injury  

Manufacturer Narrative

This is the 4 of 5 reports.The subject device is not available.

Event Description

During the procedure, it was reported that the flow diverter was inserted into the catheter to reach the target lesion, but the flow diverter could not be deployed due to the tortuosity in ica (internal carotid artery).So the device was removed but the device was prematurely deployed in the catheter during removal.Therefore, the physician retrieved both the flow diverter and catheter together.Then the second attempt was made with a new flow diverter and a new catheter (subject device), and it was successful.Post balloon angioplasty was performed with balloon catheter, and the patient woke up fine.However, the same day after the procedure, the patient experienced right sided weakness prior to discharge.Upon scan, it was determined that the patient had experienced multiple small strokes and was not doing well.Hence, the patient had to stay in the hospital for monitoring longer than anticipated due to symptoms.The patient is discharged now with some symptoms maintain.In the physician¿s opinion, the patient¿s post procedure complication was causally related to the vessel manipulation, and the vessel manipulation was due to the need for removal of the system (flow diverter and catheter) and advancement of a new system (flow diverter and catheter) into the anatomy.Post balloon angioplasty was also performed post deployment to help the device ¿open¿ for wall apposition.

Manufacturer Narrative

The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned; therefore, physical as well as a functional evaluation could not be performed.The reported issue is covered in the device directions for use.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.As per the additional information, no anomalies were noted to the device prior to the procedure and the dfu (direction for use) was followed during the preparation of the device.A probable cause of anticipated procedural complication will be assigned to the reported patient stroke and patient neurological deficit (right sided weakness), as a product related root cause does not apply and the issue is due to a known physiological effect of the procedure and/or patient condition noted with the directions for use, product labelling and/or risk documentation files.

Event Description

During the procedure, it was reported that the flow diverter was inserted into the catheter to reach the target lesion, but the flow diverter could not be deployed due to the tortuosity in ica (internal carotid artery).So the device was removed but the device was prematurely deployed in the catheter during removal.Therefore, the physician retrieved both the flow diverter and catheter together.Then the second attempt was made with a new flow diverter and a new catheter (subject device), and it was successful.Post balloon angioplasty was performed with balloon catheter, and the patient woke up fine.However, the same day after the procedure, the patient experienced right sided weakness prior to discharge.Upon scan, it was determined that the patient had experienced multiple small strokes and was not doing well.Hence, the patient had to stay in the hospital for monitoring longer than anticipated due to symptoms.The patient is discharged now with some symptoms maintain.In the physician¿s opinion, the patient¿s post procedure complication was causally related to the vessel manipulation, and the vessel manipulation was due to the need for removal of the system (flow diverter and catheter) and advancement of a new system (flow diverter and catheter) into the anatomy.Post balloon angioplasty was also performed post deployment to help the device ¿open¿ for wall apposition.

• Brand Name: AXS CATALYST 5 - 058X115 (FDA)
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9009443
• MDR Text Key: 160892183
• Report Number: 3008881809-2019-00271
• Device Sequence Number: 1
• Product Code: DQY
• UDI-Device Identifier: 07613327012019
• UDI-Public: 07613327012019
• Combination Product (y/n): N
• PMA/PMN Number: K151667
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/16/2021
• Device Catalogue Number: M003IC0581150
• Device Lot Number: 21165590
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SURPASS FLOW DIVERTER (STRYKER)
• Patient Outcome(s): Hospitalization; Other