MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Model Number 90186

Device Problems Fracture (1260); Difficult to Remove (1528)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/02/2020

Event Type  Injury  

Manufacturer Narrative

Subject device is not available.

Event Description

It was reported that during removal of a clot in m1 segment of the middle cerebral artery, the physician pulled the subject stent retriever in an attempt to withdraw it and felt resistance.The subject stent retriever fractured at the distal delivery wire, just proximal to the retriever while it was inside patient's anatomy.The patient anatomy was noted to be tortuous and the physician made no further attempts to remove the subject device fragment or the un-retrieved clot.Surgical delay occurred but duration is unknown.Additional medication given due to event is also unknown.The procedure was not completed successfully and patient condition remains the same as at admission as the clot was not able to be removed.No further information is available.

Manufacturer Narrative

Based on the results of the dhr review, there is no indication that the device, labeling or packaging failed to meet its specifications when released.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.Additional information provided by the customer indicated the patient anatomy was tortuous, continuous flush was maintained throughout the procedure, no damage noted to the packaging prior to preparation of the device, and there was resistance encountered during initial pull before it detached.In addition, an image taken during the procedure was provided and confirmed initial report of stent left in patient.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, a cause of 'undeterminable' shall be assigned to the as reported retriever fracture/broken during use, un-retrieved device fragments, and difficult/unable to withdraw retriever.

Event Description

It was reported that during removal of a clot in m1 segment of the middle cerebral artery, the physician pulled the subject stent retriever in an attempt to withdraw it and felt resistance.The subject stent retriever fractured at the distal delivery wire, just proximal to the retriever while it was inside patient's anatomy.The patient anatomy was noted to be tortuous and the physician made no further attempts to remove the subject device fragment or the un-retrieved clot.Surgical delay occurred but duration is unknown.Additional medication given due to event is also unknown.The procedure was not completed successfully and patient condition remains the same as at admission as the clot was not able to be removed.No further information is available.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• 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: 10577535
• MDR Text Key: 208298237
• Report Number: 3012931345-2020-00146
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (y/n): N
• PMA/PMN Number: K143077
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/28/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000030418
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MARKSMAN 027 160CM CATHETER (UNKNOWN); ZOOM 071 ASPIRATION SYSTEM (UNKNOWN)
• Patient Outcome(s): Other