MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 3MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number 90183

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

Patient Problems Embolus (1830); Intracranial Hemorrhage (1891); Embolism/Embolus (4438)

Event Date 08/10/2020

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during a thrombectomy procedure in the right distal m1 and m2 vessels, the physician made three successful previous passes using another retriever, subject stent retriever and aspiration catheter.A thrombolysis in cerebral infarction (tici) score of 2a was achieved.During the fourth pass with the subject stent retriever, the clot moved to the right distal m1.Aspiration thrombectomy was performed during the last pass to successfully remove the clot, and the final tici score was 1.The physician reported difficulty deploying the subject stent retriever due to unknown reasons.The patient developed symptomatic sub-arachnoid hemorrhage after the procedure without any related vessel perforation or dissection.24 hours after the procedure, imaging showed intra-cranial hemorrhage.Physician's opinion on what caused the hemorrhage was not provided.Patient condition and medical treatment administered for the hemorrhage is unknown.No further information is available.

Event Description

It was reported that during a thrombectomy procedure in the right distal m1 and m2 vessels, the physician made three successful previous passes using another retriever, subject stent retriever and aspiration catheter.A thrombolysis in cerebral infarction (tici) score of 2a was achieved.During the fourth pass with the subject stent retriever, the clot moved to the right distal m1.Aspiration thrombectomy was performed during the last pass to successfully remove the clot, and the final tici score was 1.The physician reported difficulty deploying the subject stent retriever due to unknown reasons.The patient developed symptomatic sub-arachnoid hemorrhage after the procedure without any related vessel perforation or dissection.24 hours after the procedure, imaging showed intra-cranial hemorrhage.Physician's opinion on what caused the hemorrhage was not provided.Patient condition and medical treatment administered for the hemorrhage is unknown.No further information is available.

Manufacturer Narrative

The device history record (dhr) could not be reviewed because the lot number remains unknown, however, there are controls in the manufacturing process to ensure the product met specifications upon release.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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.Information from the complaint indicated that there was a deployment failure during the procedure, but vessel perforation or vessel dissection related to trevo did not occur.Based on the investigation, it is unclear whether the reported embolization to new territory and intracerebral and subarachnoid hemorrhage 24 hours after the procedure were directly caused by the subject device.While there are a number of potential causes for the reported issue, because review and analysis of available information fails to indicate an assignable cause or probable assignable cause, undeterminable will be assigned to this complaint.

• Brand Name: TREVO XP PROVUE 3MM 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: 10505835
• MDR Text Key: 206084582
• Report Number: 3012931345-2020-00135
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (y/n): N
• PMA/PMN Number: K133464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 90183
• Device Catalogue Number: 90183
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PHENOM27 CATHETER (UNKNOWN); PHENOM27 CATHETER (UNKNOWN)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 60 YR