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 Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/25/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the procedure on stroke patient (clot was in ica-internal carotid artery and m1), the stent retriever (subject device) detached.Multiple attempts were made by surgeon to snared it out, but retriever was left in patients brain in m1 vasculature.Medication was administered to the patient.The procedure was not completed and the clot was not able to be removed (clot still in m1).According to the physician, the issues were related to the subject device.The patient clinical condition is not good, experiencing symptoms related to the clot and the acute nature of the event.
Event or Problem Description
It was reported that during the procedure on stroke patient (clot was in ica-internal carotid artery and m1), the stent retriever (subject device) detached.Multiple attempts were made by surgeon to snared it out, but retriever was left in patients brain in m1 vasculature.Medication was administered to the patient.The procedure was not completed and the clot was not able to be removed (clot still in m1).According to the physician, the issues were related to the subject device.The patient clinical condition is not good, experiencing symptoms related to the clot and the acute nature of the event.
Additional Manufacturer Narrative
The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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.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 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 continuous flush was maintained throughout the procedure, no resistance was encountered during advancement of the retriever through the microcatheter or to the lesion, and the retriever was able to successfully deploy and integrate with the clot before it had detached.The device and clot were unable to be removed after attempted retrieval with another 6mm retriever, 2 snares, and an embotrap.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable will be assigned to this complaint.

• 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: 9935762
• Report Number: 3012931345-2020-00058
• Device Sequence Number: 701139
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• 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): 05/29/2020

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: 08/18/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000031587
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/26/2020
• Supplement Date Received by Manufacturer: 05/29/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 05/29/2020
• 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: 2 UNKNOWN DEVICES (UNKNOWN MANUFACTURER); EMBOTRAP (JOHNSON & JOHNSON); TREVO 6X25 (STRYKER); TREVO 6X25 RETRIEVER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention