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

Model Number	90183
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem 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.
Additional 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 or Problem 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 3MM X 20MM
• 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: 10820873
• Report Number: 3012931345-2020-00190
• Device Sequence Number: 14402793
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133464
• 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): 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
• Operator of Device: Health Professional
• Device Model Number: 90183
• Device Catalogue Number: 90183
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/13/2020
• Supplement Date Received by Manufacturer: 12/18/2020
• Initial Report FDA Received Date: 11/10/2020
• Supplement Report FDA Received Date: 12/22/2020
• 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: TREVO XP PROVUE RETRIEVER 4X30 (STRYKER).
• Patient Age: 88 YR