MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 3MM X 20MM; CATHETER, THROMBUS RETRIEVER

Catalog Number	90183
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the subject stent retriever was pulled out after one pull, physician saw that there was a loose thread at the end of the subject stent retriever.It may appear that parts of the subject stent retriever have come loose.Procedure was completed successfully without any clinical consequences to the patient.
Additional Manufacturer Narrative
B1 adverse event - corrected - no malfunction.B5 - executive summary - updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H1 type of reportable event - corrected - no malfunction.H3 device evaluated by mfg ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual and microscopic inspection, it was observed that subject stent retriever insertion tool was noted to be kinked/bent, retriever shaped section was intact, and retriever coils were noted to be damaged.A foreign material was noted wrapped around the distal end of the retriever shaped section.Functional inspection was not required as retriever fracture/broken during use was not confirmed based on visual inspection.The reported event is covered in the device direction 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.The reported event retriever fracture/broken during use was not confirmed as it was noted that a foreign material/wire was attached to the distal end of the retriever, no damage was noted to the retrieve, it is likely that it was perceived that the retriever was fractured.The analysis results are consistent with the reported event.The retuned device failed to meet specification when returned due to the damage noted to the device.The device was returned and there was no damage noted to the retriever shaped section, there was some bending noted to the insertion tool and there was some slight damage noted to the retriever coils, both of these anomalies would not be related to the foreign material (wire) found attached to the retriever.The reported retriever fractured/broken during use was not confirmed during analysis, therefore an assignable cause of not confirmed will be assigned.It is likely that the retriever may have come in contact with another device during preparation or during use causing the analyzed foreign material.Therefore, an assignable cause of caused by other will be assigned to the analyzed retriever contaminated.It is likely that the retriever coils were slightly damaged during the clinical procedure, therefore an assignable cause of procedural factors will be assigned.It is likely that the insertion tool was damaged as a result of handling of the device prior to use, therefore an assignable cause of handling damage will be assigned to the analyzed retriever insertion tool kinked/bent.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that when the subject stent retriever was pulled out after one pull, physician saw that there was a loose thread at the end of the subject stent retriever.It may appear that parts of the subject stent retriever have come loose.Procedure was completed successfully without any clinical consequences to the patient.Update: the subject stent retriever was returned for analysis and was examined, and it was discovered that the reported event of the subject stent retriever being broken/fracture during use was not confirmed.The subject retriever insertion tool was noted to be kinked/bent, coils were damaged, and a foreign material was noted wrapped around the distal end of the retriever shaped section.

• Brand Name: TREVO XP PROVUE 3MM X 20MM
• Common Device Name: CATHETER, THROMBUS RETRIEVER
• Manufacturer (Section D): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer (Section G): STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY; 4870 west 2100 south; salt lake city UT 84120
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 21678659
• Report Number: 3012931345-2025-00066
• Device Sequence Number: 7693753
• Product Code: NRY
• UDI-Device Identifier: 00815742001839
• UDI-Public: (01)00815742001839(17)260507(10)0000660466
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K132641
• 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): 05/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2026
• Device Catalogue Number: 90183
• Device Lot Number: 0000660466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2025
• Supplement Date Received by Manufacturer: 05/07/2025
• Initial Report FDA Received Date: 03/24/2025
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male