MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number 90182

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the procedure the subject stent retriever was broken inside the clot.It was left inside the patient's m2 vessel.The patient's anatomy was reported to be severely tortuous.There was unknown length of surgical delay reported and the procedure was not completed successfully.No further information is available.

Event Description

It was reported that during the procedure the subject stent retriever was broken inside the clot.It was left inside the patient's m2 vessel.The patient's anatomy was reported to be severely tortuous.There was unknown length of surgical delay reported and the procedure was not completed successfully.No further information is available.

Manufacturer Narrative

H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.D4 expiration date - added.D9/h3 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.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 device was returned.The reported lot number was confirmed from the returned packaging.During visual inspection, the retriever shaped section was detached from the distal end of the device.The proximal coil was kinked and stretched.The core wire could be seen at the proximal end of the proximal coil.The proximal coil was removed to locate the core wire fracture and it was noted to be fractured at the proximal coil/core wire bond.Functional testing was not required as the defect was visually confirmed.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 was received indicating the stent remains in the patient and will not be attempted to remove the stent.Also the patient had severely tortuous anatomy which may have contributed to the event.Based on the information provided, it is most likely that the trevo retriever stent became dislodged from the device itself due to anatomical or procedural factors encountered during the procedure which then resulted in the un-retrieved device fragment.An assignable cause of procedural factors will be assigned to the as reported retriever fractured/broken during use and un-retrieved device fragments, as well as the as analyzed defects retriever coil damaged and retriever core wire broken/fractured during use as this issue appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.

• Brand Name: TREVO XP PROVUE 4MM X 20MM
• 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: 11859569
• MDR Text Key: 255352927
• Report Number: 3012931345-2021-00073
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001822
• UDI-Public: 00815742001822
• Combination Product (y/n): N
• PMA/PMN Number: K132641
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 07/30/2021

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: 02/18/2022
• Device Model Number: 90182
• Device Catalogue Number: 90182
• Device Lot Number: 0000041290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 07/06/2021
• Supplement Dates FDA Received: 07/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other