MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 4MM X 30MM; CATHETER, THROMBUS RETRIEVER

Model Number	90185
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, the subject stent retriever was used during two to three thrombectomy attempts.Physician is reported to have applied a significant amount of force to the proximal end of the subject retriever, when a fracture occurred.The fracture was noted at the proximal part of the subject stent retriever, when unsheathing from the micro catheter while inside the target vessel.Physician tried to remove the broken fragment of the subject stent retriever with another stent but was unsuccessful.The clot is reported to have been partially removed through aspiration.Patient was given unknown additional medication due to this event.Patient condition is a little better post procedure.No other information is available.
Additional Manufacturer Narrative
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.On initial inspection, the device was returned.The reported lot number was confirmed from the returned packaging.On visual/microscopic inspection, the stent was not returned.The proximal coil was kinked/damaged.The retriever core wire was broken/fractured.A functional test was unable to be performed due to the damage noted to the device.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.In the case of this complaint, it is probable that anatomical factors encountered during the procedure contributed to the stent retriever breaking and being left behind in the patient.An assignable cause of procedural factors will be assigned to the as reported (ar) and as analyzed (aa) 'retriever core wire broken during use' and ar 'un-retrieved device fragments' as well as the aa 'retriever coils damaged' since these issues appear 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.
Event or Problem Description
It was reported that during the procedure, the subject stent retriever was used during two to three thrombectomy attempts.Physician is reported to have applied a significant amount of force to the proximal end of the subject retriever, when a fracture occurred.The fracture was noted at the proximal part of the subject stent retriever, when unsheathing from the micro catheter while inside the target vessel.Physician tried to remove the broken fragment of the subject stent retriever with another stent but was unsuccessful.The clot is reported to have been partially removed through aspiration.Patient was given unknown additional medication due to this event.Patient condition is a little better post procedure.No other information is available.

• Brand Name: TREVO XP PROVUE 4MM X 30MM
• 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: 10932279
• Report Number: 3012931345-2020-00208
• Device Sequence Number: 11343474
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K150616
• 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): 03/10/2021

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: 09/18/2021
• Device Model Number: 90185
• Device Catalogue Number: 90185
• Device Lot Number: 0000033087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2021
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 02/26/2021
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TREVO PRO 18 MICRO CATHETER (STRYKER); TREVO PRO 18 MICRO CATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 59 YR
• Patient Weight: 70