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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage, Subarachnoid (1893)
Date of Event	01/26/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
During treatment of thrombosis in left m2, the subject retriever was used to remove the thrombosis.The patient mrs (modified rankin scale) pre procedure was unknown.Preprocedure patient had a modified treatment in cerebral ischemia (mtici) grade of 0 and a post operation mtici grade of 2a was achieved.It was reported that symptomatic intracranial hemorrhage (sah) occurred twos days after procedure.The patient¿s current condition is unknown.Physician noted that subject device did not cause sah in patient, rather the patient sah was likely due to poor condition at time of transportation and target blood vessels was thin.No additional follow-up procedure to treat patient sah is planned.No further information is available.
Event or Problem Description
During treatment of thrombosis in left m2, the subject retriever was used to remove the thrombosis.The patient mrs (modified rankin scale) pre procedure was unknown.Preprocedure patient had a modified treatment in cerebral ischemia (mtici) grade of 0 and a post operation mtici grade of 2a was achieved.It was reported that symptomatic intracranial hemorrhage (sah) occurred twos days after procedure.The patient¿s current condition is unknown.Physician noted that subject device did not cause sah in patient, rather the patient sah was likely due to poor condition at time of transportation and target blood vessels was thin.No additional follow-up procedure to treat patient sah is planned.No further information is available.
Additional 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 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.Additional information provided by the customer indicated that no anomalies were noted to the device during preparation/prior to use, the device was prepared as per the dfu, and the device performed as intended during the procedure.It was noted that the physician thought the reason for the bleeding was that the patient was in very poor condition at the time of transportation and the target blood vessel was thin.The reported patient intracranial hemorrhage is a known and anticipated complication to these types of procedures and patient condition and is listed as such in the device directions for use.Therefore, an assignable cause of anticipated procedural complication will be assigned to this event.

• 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: 10221488
• Report Number: 3012931345-2020-00094
• Device Sequence Number: 16745365
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (Y/N): N
• 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): 08/19/2020

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?: No
• Operator of Device: Health Professional
• Device Model Number: 90183
• Device Catalogue Number: 90183
• Device Lot Number: 0000027856 ¿0000025589
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/02/2020
• Supplement Date Received by Manufacturer: 08/17/2020
• Initial Report FDA Received Date: 07/01/2020
• Supplement Report FDA Received Date: 08/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR