MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number 90182

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

Patient Problems Embolus (1830); Occlusion (1984); Thromboembolism (2654); Embolism/Embolus (4438)

Event Date 07/03/2020

Event Type  Injury  

Manufacturer Narrative

The subject device is unavailable to manufacturer.

Event Description

It was reported that during the study procedure with the subject device (retriever), the distal occlusion in aca territory (a1) and new ent (embolization to new territory) to a2 were occurred.The adverse events were treated by recanalization/thrombectomy.The procedure was completed, and the events were resolved with tici (thrombolysis in cerebral infarction score) of 2a was achieved.It¿s indicated that there was relationship between the adverse events to the index stroke, index procedure and the technique was not successful due to subject device (retriever) deployment failure.No other information was provided.

Manufacturer Narrative

Based on the results of the dhr 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 the technique was not successful due to the stent retriever deployment failure.Since the device was not returned for analysis, the cause of the deployment failure could not be definitively determined.Additionally, based on the information provided, the causal relationship between the subject device and the reported distal occlusion and ent is unknown.Therefore, undeterminable will be assigned to this complaint since review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.

Event Description

It was reported that during the study procedure with the subject device (retriever), the distal occlusion in aca territory (a1) and new ent (embolization to new territory) to a2 were occurred.The adverse events were treated by recanalization/thrombectomy.The procedure was completed, and the events were resolved with tici (thrombolysis in cerebral infarction score) of 2a was achieved.It¿s indicated that there was relationship between the adverse events to the index stroke, index procedure and the technique was not successful due to subject device (retriever) deployment failure.No other information was provided.Updated information: received additional information on 9/4/2020 indicated that the the distal occlusion was caused by iatrogenic embolization during procedure and tortuous anatomy.

• Brand Name: TREVO XP PROVUE 4MM X 20MM
• 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: 10336163
• MDR Text Key: 200772585
• Report Number: 3012931345-2020-00109
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (y/n): N
• PMA/PMN Number: K132641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 09/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2021
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: 0000032043
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 63 YR