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

Catalog Number	M003IC0581150
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Stroke/CVA (1770); Neurological Deficit/Dysfunction (1982)
Date of Event	08/20/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 3 of the 5 reports.The subject device is not available.
Event or Problem Description
During the procedure, it was reported that the flow diverter was inserted into the catheter (subject device) 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, 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.
Additional 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 or Problem Description
During the procedure, it was reported that the flow diverter was inserted into the catheter (subject device) 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, 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)
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9000767
• Report Number: 3008881809-2019-00270
• Device Sequence Number: 11375352
• Product Code: DQY
• UDI-Device Identifier: 07613327012019
• UDI-Public: 07613327012019
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K151667
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2020
• Device Catalogue Number: M003IC0581150
• Device Lot Number: 20762141
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/11/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SURPASS FLOW DIVERTER (STRYKER)
• Outcome Attributed to Adverse Event: Hospitalization; Other