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	Difficult to Remove (1528)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Vascular Dissection (3160)
Date of Event	01/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during a thrombectomy procedure, the subject device was done for right m1-distal cardio embolic and the vessel dissection occurred which related to the subject device.When using the subject device, the doctor felt the difficulty deploying and withdrawal.The subject device was finally removed and completed the procedure.After that, the bleeding was confirmed as hi type 1 based on european cooperative acute stroke study (ecass) classification.19 days post procedure assessed having a modified rankin scale (mrs) of 3.No further information was provided.
Event or Problem Description
It was reported that during a thrombectomy procedure, the subject device was done for right m1-distal cardio embolic and the vessel dissection occurred which related to the subject device.When using the subject device, the doctor felt the difficulty deploying and withdrawal.The subject device was finally removed and completed the procedure.After that, the bleeding was confirmed as hi type 1 based on european cooperative acute stroke study (ecass) classification.19 days post procedure assessed having a modified rankin scale (mrs) of 3.No further information was provided.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 the device was confirmed to be in good condition prior to use and was prepared as per the device directions for use (dfu).It is unknown what associated devices were used in the procedure.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 for analysis, a cause of undeterminable will be assigned to the ' retriever shaped section will not fully open inside vessel' and ' difficult/unable to withdraw retriever'.Based upon medical review assessment, the data reasonably suggests the clinical event is anticipated in nature as per the dfu.Therefore, a probable cause of anticipated procedural complication will be assigned to the 'patient vessel dissection' and 'patient intracranial hemorrhage'.

• 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: 9696242
• Report Number: 3012931345-2020-00022
• Device Sequence Number: 16566823
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• 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): 03/31/2020

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: 04/15/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000025597
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/28/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 02/11/2020
• Supplement Report FDA Received Date: 03/31/2020
• 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: 87 YR