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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/12/2020

Event Type  malfunction  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

During the thrombolysis performed for right m2, passes were done with subject retriever.There were no vessel perforation, or vessel dissection, but physician noted difficulty removing subject retriever occurred during procedure.Final tici (thrombolysis in cerebral infarction) score was 2b, and no hemorrhage observed in follow-up ct, and mri after procedure.No further information provided.

Manufacturer Narrative

Although the dhr could not be reviewed because the lot number remains unknown, 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.As the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause for the reported event, an assignable cause of undeterminable will be assigned to this complaint.

Event Description

During the thrombolysis performed for right m2, passes were done with subject retriever.There were no vessel perforation or vessel dissection, but physician noted difficulty removing subject retriever occurred during procedure.Final tici (thrombolysis in cerebral infarction) score was 2b and no hemorrhage observed in follow-up ct and mri after procedure.No further information provided.

• 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: 10820874
• MDR Text Key: 216212162
• Report Number: 3012931345-2020-00189
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/13/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/18/2020
• Supplement Dates FDA Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TREVO XP PROVUE RETRIEVER 3X20 (STRYKER).
• Patient Age: 88 YR