MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE RETRIEVER 3X20 + TREVO PRO 14 MC KIT; CATHETER, THROMBUS RETRIEVER

Catalog Number	80051
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that when the subject device (retriever) was in the m2 segment for approximately 4 minutes; the physician retracted the retriever 3/4 of the way into the catheter; the retriever broke off and it was wedged in the catheter.The physician was able to pull catheter out with the retriever.There were no reported clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
Updated lot # is unknown.Although the lot number was not provided, the automated manufacturing execution system (mes) has 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 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.Based on the information currently available an assignable cause for this event cannot be determined.
Event or Problem Description
It was reported that when the subject device (retriever) was in the m2 segment for approximately 4 minutes; the physician retracted the retriever 3/4 of the way into the catheter; the retriever broke off and it was wedged in the catheter.The physician was able to pull catheter out with the retriever.There were no reported clinical consequences to the patient due to this event.

• Brand Name: TREVO XP PROVUE RETRIEVER 3X20 + TREVO PRO 14 MC KIT
• 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: 9154014
• Report Number: 3012931345-2019-00078
• Device Sequence Number: 3185866
• Product Code: NRY
• UDI-Device Identifier: 00815742000511
• UDI-Public: 00815742000511
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• 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): 12/04/2019

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 Catalogue Number: 80051
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/18/2019
• Supplement Date Received by Manufacturer: 11/19/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR