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

Catalog Number 90182

Device Problem Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/19/2020

Event Type  Injury  

Event Description

It was reported that during the procedure of thrombectomy, the retriever (subject device) detached during procedure.The physician attempted to remove the subject retriever using a snare device.All attempts to retrieve the subject device were unsuccessful causing a surgical delay.The subject retriever remains in m1 inside the patient¿s anatomy.It was reported that the patient is under added medication.There were no clinical consequences reported to the patient.

Manufacturer Narrative

H4 manufacturing date ¿ added; h3 device evaluated by mfg ¿updated; h3 summary attached - updated; d4 expiration date - added; d10 product available to stryker ¿ updated; d10 returned to manufacturer on ¿updated.The device was returned and was confirmed to be a trevo xp provue retriever.During visual inspection, after decontamination the trevo xp provue device was examined and it was observed that the trevo xp provue retriever was not attached to the returned unit.The device core wire and shaft coil were examined.The shaft coil was kinked and stretched and the core wire was broken.Sem imaging of the fractured core wire was performed with feedback from r&d and the fracture location was confirmed at the round-to-flat transition area on core wire.The fracture surface was observed to have a "two-zone" fracture; where both brittle fracture and ductile fracture regions are present.Fracture was low cycle fatigue (fatigue crack initiated at one side of the surface) with ductile overload failure.Approximately 85% of the fracture was due to ductile overload failure (fast fracture).It was also noted that there was significant contamination on the fracture surface (dark spots), which is likely dried procedural fluids.Functional inspection testing was not performed due to the condition the device was received.From the condition of the product it appears that the product had been under excessive manipulation.Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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 that the device was prepared as per the dfu, no anomalies noted to the device after removal from the packaging or prior to preparation, and continuous flush was maintained throughout the procedure.Based on the information provided, it is most likely that the device became dislodged from the device itself due to anatomical or procedural factors encountered during the procedure.An assignable cause of procedural factors will be assigned to the complaint, 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.This complaint has been identified to be within the scope of nc# 2425934, which was raised for core wire fracture.The subsequent investigation of this nc led to containment and recall per hhe# 2430533.

Event Description

It was reported that during the procedure of thrombectomy, the retriever (subject device) detached during procedure.The physician attempted to remove the subject retriever using a snare device.All attempts to retrieve the subject device were unsuccessful causing a surgical delay.The subject retriever remains in m1 inside the patient¿s anatomy.It was reported that the patient is under added medication.There were no clinical consequences reported to the patient.

• 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: 10504669
• MDR Text Key: 206083870
• Report Number: 3012931345-2020-00133
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742000528
• UDI-Public: 00815742000528
• 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: 11/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/27/2021
• Device Catalogue Number: 90182
• Device Lot Number: 0000032043
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2020
• Date Manufacturer Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ASPIRATION PUMP (UNKNOWN MANUFACTURER; MICROCATHETER (STRYKER); SNARE DEVICE (UNKNOWN MANUFACTURER)
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 71 YR