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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/26/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device not returned.
Event or Problem Description
It was reported that the subject retriever was used during thrombectomy procedure for the distal right m1 and right cervical- internal carotid artery (ica) occlusion.The modified ranking scale (mrs) score was 0 and alberta stroke program early ct score (asoects) was 3 before the procedure.During the first pass in the m1- distal, the subject retriever was broken.There were no vessel dissection or vessel perforation during the procedure.No hemorrhage after the procedure was confirmed.Non-stryker retriever and aspiration catheter were used to complete the procedure successfully.A stent was deployed in the cervical -ica after treating m1-distal occlusion.Successful recanalization with tici (thrombolysis in cerebral infarction score) of 3 was achieved.No clinical consequences were reproved due to this event.No additional information was provided.
Event or Problem Description
It was reported that the subject retriever was used during thrombectomy procedure for the distal right m1 and right cervical- internal carotid artery (ica) occlusion.The modified ranking scale (mrs) score was 0 and alberta stroke program early ct score (asoects) was 3 before the procedure.During the first pass in the m1- distal, the subject retriever was broken.There were no vessel dissection or vessel perforation during the procedure.No hemorrhage after the procedure was confirmed.Non-stryker retriever and aspiration catheter were used to complete the procedure successfully.A stent was deployed in the cervical -ica after treating m1-distal occlusion.Successful recanalization with tici (thrombolysis in cerebral infarction score) of 3 was achieved.No clinical consequences were reproved due to this event.No additional information was 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.Visual and functional testing could not be performed since the device was not returned for investigation.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.It was reported that the subject trevo retriever was broken during the procedure.Additional information provided by the customer indicated that the device was prepared as per the dfu, a phenom 27 microcatheter was used with the subject stent retriever, and thrombectomy was completed with a non-stryker stent retriever and aspiration catheter after the trevo broke.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 and the device was not returned, an assignable 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: 10814336
• Report Number: 3012931345-2020-00187
• Device Sequence Number: 4177743
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/15/2021

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: 90186
• Device Catalogue Number: 90186
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/28/2020
• Supplement Date Received by Manufacturer: 12/22/2020
• Initial Report FDA Received Date: 11/09/2020
• Supplement Report FDA Received Date: 01/15/2021
• 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: PHENOM27 MIROCATHETER (MEDTRONIC); PHENOM27 MIROCATHETER (MEDTRONIC)
• Patient Age: 53 YR