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

Model Number 90186

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/02/2020

Event Type  Injury  

Manufacturer Narrative

Device is not available to manufacturer.

Event Description

It was reported that during a thrombectomy procedure, the subject stent retriever was used in combination with a catheter.During delivery of the subject stent retriever in the internal carotid terminus to m1 segment, its delivery wire fractured at the distal part.The physician did not apply significant force during maneuver.The subject stent retriever fragment was left inside the patient's anatomy with no other plans to remove it.Patient was reported to be stable post procedure with no additional medication due to this event.No other information is available.

Event Description

It was reported that during a thrombectomy procedure, the subject stent retriever was used in combination with a catheter.During delivery of the subject stent retriever in the internal carotid terminus to m1 segment, its delivery wire fractured at the distal part.The physician did not apply significant force during maneuver.The subject stent retriever fragment was left inside the patient's anatomy with no other plans to remove it.Patient was reported to be stable post procedure with no additional medication due to this event.No other information is available.

Manufacturer Narrative

H4: manufacturing date: added.D4: expiration date: added.Based on the results of the device history record (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.It was reported that during the procedure the stent retriever (subject device) came off the delivery wire at the beginning of the trevo / cat7 withdrawal.Additional information provided by the customer indicated that no anomalies were noted to the device after removal from the packaging or prior to preparation, the device was prepared as per the dfu, continuous flush maintained throughout the procedure, and there were no issues with delivery / deployment of the retriever.The fractured stent fragment was left in the patient with no plans for further medical intervention to remove from the patient's anatomy.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of 'undeterminable' will be assigned to this complaint.

• 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: 10845126
• MDR Text Key: 216411893
• Report Number: 3012931345-2020-00196
• 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: 01/29/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 12/18/2021
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000038320
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/16/2020
• Supplement Dates Manufacturer Received: 01/27/2021
• Supplement Dates FDA Received: 01/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CATALYST 7 CATHETER (STRYKER).; CATALYST 7 CATHETER (STRYKER)
• Patient Outcome(s): Other