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

Catalog Number	90185
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that the subject stent retriever was used for acute ais (acute ischemic stroke) procedure, as the cta (computed tomography angiography) showed a long occlusion at the left mca (middle cerebral artery).The operator-built access and then used the subject stent retriever to perform a thrombectomy.After the first attempt, the vessel was not completely clear, therefore; the second attempt was made, the big resistance was encountered when advancing the subject stent retriever into the retriever microcatheter.The subject stent retriever was removed from the patient's anatomy and found the distal of the subject stent retriever platinum coil was damaged.The operator replaced it with the catalyst catheter for aspiration and finished the procedure.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
There are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the device was returned and the retriever platinum coil was noted to be broken to the distal end of the retriever shaped section.The retriever distal coil was kinked and there was resistance experienced in the attempt to advance the retriever into the microcatheter hub.Functional testing was performed as the insertion tool was flushed without difficulty.The core wire was advanced to push the retriever out of the insertion tool into the demo microcatheter hub with slight friction experienced.The retriever was expanded once advanced from the sheath without difficulty.The reported events were confirmed during analysis.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.The device failed to meet specification when returned based on the damage noted.It was reported that after the first try, the vessel was not completely clear so the operator used it to do second try.However big resistance was encountered when advancing the stent to go into pro18 device, so the operator took the stent out and found distal of the stent was damaged.It is probable that the damage noted occurred during the initial retrieval attempt or during the attempt to re-load the retriever into the insertion tool or microcatheter.An assignable cause of procedural factors will be assigned to the reported 'retriever difficult/unable to to be advanced into catheter hub', 'retriever platinum wire damage/break' and to the analysed 'retriever platinum wire damage/break', 'retriever coils damaged' and 'retriever difficult/unable to be advanced into catheter hub', as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
It was reported that the subject stent retriever was used for acute ais (acute ischemic stroke) procedure, as the cta (computed tomography angiography) showed a long occlusion at the left mca (middle cerebral artery).The operator-built access and then used the subject stent retriever to perform a thrombectomy.After the first attempt, the vessel was not completely clear, therefore; the second attempt was made, the big resistance was encountered when advancing the subject stent retriever into the retriever microcatheter.The subject stent retriever was removed from the patient's anatomy and found the distal of the subject stent retriever platinum coil was damaged.The operator replaced it with the catalyst catheter for aspiration and finished the procedure.No clinical consequences were reported to the patient due to this event.

• 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
• 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: 18519686
• Report Number: 3012931345-2024-00008
• Device Sequence Number: 6751372
• Product Code: NRY
• UDI-Device Identifier: 00815742001853
• UDI-Public: 00815742001853
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/07/2024

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: 06/06/2024
• Device Catalogue Number: 90185
• Device Lot Number: 0000141425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 02/15/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CATALYST 7 CATHETER (STRYKER); PRO-18 MICROCATHETER (STRYKER)
• Patient Sex: Unknown