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

Model Number	90185
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	02/10/2020
Type of Reportable Event	Death
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem 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was pulled, but it was stuck, and could not be stored in the catheter.Finally, the subject device (retriever) was withdrawn together with the catheter, and the subject device (retriever) was removed from the catheter (the stent was not transected).The bleeding area was treated with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).
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3012931345-2020-00176
• Device Sequence Number: 4089780
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K150616
• 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): 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
• Operator of Device: 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 Received by Manufacturer: 10/12/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 01/12/2021
• 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: GUIDEWIRE (UNKNOWN MANUFACTURING); MARKSMAN MICROCATHETER; GUIDEWIRE (UNKNOWN MANUFACTURING); MARKSMAN MICROCATHETER
• Outcome Attributed to Adverse Event: Death; Other