MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Model Number	90186
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/02/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during removal of a clot in m1 segment of the middle cerebral artery, the physician pulled the subject stent retriever in an attempt to withdraw it and felt resistance.The subject stent retriever fractured at the distal delivery wire, just proximal to the retriever while it was inside patient's anatomy.The patient anatomy was noted to be tortuous and the physician made no further attempts to remove the subject device fragment or the un-retrieved clot.Surgical delay occurred but duration is unknown.Additional medication given due to event is also unknown.The procedure was not completed successfully and patient condition remains the same as at admission as the clot was not able to be removed.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 the patient anatomy was tortuous, continuous flush was maintained throughout the procedure, no damage noted to the packaging prior to preparation of the device, and there was resistance encountered during initial pull before it detached.In addition, an image taken during the procedure was provided and confirmed initial report of stent left in patient.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned, a cause of 'undeterminable' shall be assigned to the as reported retriever fracture/broken during use, un-retrieved device fragments, and difficult/unable to withdraw retriever.
Event or Problem Description
It was reported that during removal of a clot in m1 segment of the middle cerebral artery, the physician pulled the subject stent retriever in an attempt to withdraw it and felt resistance.The subject stent retriever fractured at the distal delivery wire, just proximal to the retriever while it was inside patient's anatomy.The patient anatomy was noted to be tortuous and the physician made no further attempts to remove the subject device fragment or the un-retrieved clot.Surgical delay occurred but duration is unknown.Additional medication given due to event is also unknown.The procedure was not completed successfully and patient condition remains the same as at admission as the clot was not able to be removed.No further information is available.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• 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: 10577535
• Report Number: 3012931345-2020-00146
• Device Sequence Number: 1192898
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K143077
• 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): 11/09/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000030418
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 10/21/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/09/2020
• 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: MARKSMAN 027 160CM CATHETER (UNKNOWN); ZOOM 071 ASPIRATION SYSTEM (UNKNOWN)
• Outcome Attributed to Adverse Event: Other