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 Codes	Perforation of Vessels (2135); Viral Infection (2248)
Date of Event	02/07/2021
Type of Reportable Event	Death
Additional Manufacturer Narrative
H3 other text : the subject device is unavailable to manufacturer.
Event or Problem Description
It was reported during the first treatment strategy from a thrombectomy procedure on (b)(6) 2021, the patient suffered vessel perforation /rupture on stenosed artery and hiv which were treated with the medication and subsequently there was patient death.It is noted that the adverse event has possibly relationship to the subject study retriever device, thrombectomy procedure, disease under study and to an underlying condition.No further information is available.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not 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.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.The reported 'patient death, patient vessel perforation and patient complications' 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, a probable cause of anticipated procedural complication was assigned to this event.
Event or Problem Description
It was reported during the first treatment strategy from a thrombectomy procedure on (b)(6) 2021, the patient suffered vessel perforation /rupture on stenosed artery and hiv which were treated with the medication and subsequently there was patient death.It is noted that the adverse event has possibly relationship to the subject study retriever device, thrombectomy procedure, disease under study and to an underlying condition.No further information is available.

• 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 17052823
• Report Number: 3012931345-2023-00117
• Device Sequence Number: 20574378
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 08/09/2023

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 Expiration Date: 07/08/2022
• Device Model Number: 90183
• Device Catalogue Number: 90183
• Device Lot Number: 0000048249
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 08/02/2023
• Initial Report FDA Received Date: 06/02/2023
• Supplement Report FDA Received Date: 08/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/09/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention
• Patient Sex: Unknown