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

Model Number 90183

Device Problems Break (1069); Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.Additional information provided by the customer indicted that the packaging was confirmed to be in a good condition prior to use, the device was prepared as per direction for use (dfu), continuous flush was maintained throughout the procedure.While there are several potential causes for the reported issue, because review of available information failed to identify a definitive cause and because the product was not returned for analysis, an assignable cause of undetermined was assigned to the as reported issues 'nv - retriever fracture/broken' and 'nv - un-retrieved device fragments'.Device not returned.

Event Description

It was reported that the subject stent retriever was used to perform a successful thrombectomy.Two days post procedure computed tomography (ct) indicated that two radiopaque markers inside the patient vessel.The physician assumed that the markers were possibly from the subject stent retriever.A 500mg aspirin i.V.And 600 mg clopidogrel parenteral were administered for interventional purposes.No patient adverse event associated with the device malfunction was reported.

Manufacturer Narrative

Device code grid - corrected.The initial as reported issue retriever fracture/broken was replaced with ro marker(s) detached/separated/not visible under fluoroscopy to capture the reported issue appropriately.

Event Description

It was reported that the subject stent retriever was used to perform a successful thrombectomy.Two days post procedure computed tomography (ct) indicated that two radiopaque markers inside the patient vessel.The physician assumed that the markers were possibly from the subject stent retriever.A 500mg aspirin i.V.And 600 mg clopidogrel parenteral were administered for interventional purposes.No patient adverse event associated with the device malfunction was reported.

• Brand Name: TREVO XP PROVUE RETRIEVER 3X20
• Type of Device: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 8192656
• MDR Text Key: 131300982
• Report Number: 3012931345-2018-00036
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: 00815742001839
• Combination Product (y/n): N
• PMA/PMN Number: K133464
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 08/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2020
• Device Model Number: 90183
• Device Catalogue Number: 90183
• Device Lot Number: 0000005417
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 81 YR
• Patient Weight: 86