MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO NXT 4MM X 41MM - US; CATHETER, THROMBUS RETRIEVER

Model Number	90314
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Intracranial Hemorrhage (1891); Device Embedded In Tissue or Plaque (3165)
Date of Event	06/15/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during the third pass for thrombolytic procedure, the subject retriever had detached within patient anatomy.Physician was unable to retrieve the detached subject device and subsequently completed the procedure.Patient was provided dapt (dual anti-platelet therapy) medication due to the subject device left behind.Physician reported no anomalies regarding device usage prior to detachment during third pass.Physician later reported patient had passed away due to hemorrhage.Physician confirmed that patient death was not due to subject device.No additional information provided.
Additional 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.Device was returned for analysis, the returned product was confirmed from the returned packaging.During visual inspection, the subject device was examined and it was observed that the stent was not attached to the returned unit.Polymer jacket is shown to be intact, no major stretching or deformation noted; however there is a slight bend on core wire just proximal to fracture site.Sem (scanning electron microscope) imaging of the fractured core wire was performed with r&d sustaining and the fracture location was confirmed to be distal to the round-to-flat transition area on core wire.The fracture surface was observed to have brittle fracture.The sem images show darker spots, which is likely leftover contamination from dried procedural fluids.From the condition of the product it appears that the product had been under excessive manipulation.Performance testing was not performed due to the condition the device was received.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 subject retriever stent 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 as analyzed (aa) defect of 'retriever core wire broken during use' and as reported (ar) defects of 'retriever fractured/broken during use' and 'un-retrieved device fragments', 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.Furthermore, an assignable cause of 'anticipated procedural complications' will be assigned to the ar defect of 'patient intracranial hemorrhage'.
Event or Problem Description
It was reported that during the third pass for thrombolytic procedure, the subject retriever had detached within patient anatomy.Physician was unable to retrieve the detached subject device and subsequently completed the procedure.Patient was provided dapt (dual anti-platelet therapy) medication due to the subject device left behind.Physician reported no anomalies regarding device usage prior to detachment during third pass.Physician later reported patient had passed away due to hemorrhage.Physician confirmed that patient death was not due to subject device.No additional information provided.

• Brand Name: TREVO NXT 4MM X 41MM - US
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• MDR Report Key: 10273875
• Report Number: 3012931345-2020-00099
• Device Sequence Number: 13659124
• Product Code: NRY
• UDI-Device Identifier: 07613327299946
• UDI-Public: 07613327299946
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K120961
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 90314
• Device Catalogue Number: 90314
• Device Lot Number: 0000043424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 01/29/2021
• Initial Report FDA Received Date: 07/14/2020
• Supplement Report FDA Received Date: 01/29/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention