MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER

Model Number 90185

Device Problem Difficult to Remove (1528)

Patient Problem Vascular Dissection (3160)

Event Date 02/10/2020

Event Type  Death  

Manufacturer Narrative

The subject device is unavailable to manufacturer.

Event Description

It was reported that the subject device (retriever) was used in the procedure with other devices to treat occlusion at m1.The meandering of blood vessels was weak.After easily reaching the block with the guide wire and catheter, the resistance was encountered while inserting the subject device (retriever) into the catheter, and it got stuck.After that, the physician was pushing and pulling to move the subject device (retriever), and it was suddenly jumped out of the tip of the catheter and fully deployed.At that time, the blood vessels of m2 were damaged and bleeding.The physician indicated that the resistance was caused the blood vessels to shift downwards, which caused them to tear.The subject device (retriever) was pulled, but it was stuck, and could not be stored in the catheter.Finally, the subject device (retriever) was withdrawn together with the catheter, and the subject device (retriever) was removed from the catheter (the stent was not transected).The bleeding area was treated with the catheter and the physician thought the subject device (retriever) would be easy to lift because it was easy to guide the catheter to the treatment area.It was reported that the patient had passed away 3 days after surgery and the death was related to the subject device (retriever).

Manufacturer Narrative

Based on the results of the dhr (device history record) review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 a marksman microcatheter was used in the procedure and there was no resistance as the marksman passed through the blood clot.However, the doctor felt resistance in delivering the trevo.This resistance caused the blood vessels to shift downwards, which caused them to tear.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 the subject device (retriever) was used in the procedure with other devices to treat occlusion at m1.The meandering of blood vessels was weak.After easily reaching the block with the guide wire and catheter, the resistance was encountered while inserting the subject device (retriever) into the catheter and it got stuck.After that, the physician was pushing and pulling to move the subject device (retriever), and it was suddenly jumped out of the tip of the catheter and fully deployed.At that time, the blood vessels of m2 were damaged and bleeding.The physician indicated that the resistance was caused the blood vessels to shift downwards, which caused them to tear.The subject device (retriever) was pulled but it was stuck and could not be stored in the catheter.Finally, the subject device (retriever) was withdrawn together with the catheter and the subject device (retriever) was removed from the catheter (the stent was not transected).The bleeding area was treated with the catheter and the physician thought the subject device (retriever) would be easy to lift because it was easy to guide the catheter to the treatment area.It was reported that the patient had passed away 3 days after surgery and the death was related to the subject device (retriever).

• Brand Name: TREVO XP PROVUE 4MM X 30MM
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10771535
• MDR Text Key: 214144883
• Report Number: 3012931345-2020-00176
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (y/n): N
• PMA/PMN Number: K150616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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: 07/23/2021
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: 0000030261
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/02/2020
• Supplement Dates Manufacturer Received: 12/22/2020
• Supplement Dates FDA Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: GUIDEWIRE (UNKNOWN MANUFACTURING); MARKSMAN MICROCATHETER; GUIDEWIRE (UNKNOWN MANUFACTURING); MARKSMAN MICROCATHETER
• Patient Outcome(s): Death; Other