MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO XP PROVUE 6MM X 25MM; CATHETER, THROMBUS RETRIEVER

Model Number	90186
Medical Device Problem Codes	Fracture (1260); Difficult to Remove (1528)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/21/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the subject sent device (trevo xp) was used on one right mca (middle cerebral artery) aneurysm case.Punctured through right femoral artery and placed 8f codis guide catheter, sofia aspiration catheter, pro-18 microcatheter and synchro guidewire to build access and placed middle catheter and microcatheter to the location.Prepared to use a subject device syent.Checked it and flushed it normally and then delivered it into pro18 microcatheter.After it was placed to the location, deployed it and withdrew it normally.For the first time to withdraw, no thrombus was observed.So the operator delivered it to deploy again and when withdrawing the subject stent, big resistance was encountered and the subject stent could not be retracted.Tried several times the subject stent was separated and left it in the vessel and could not be taken out with a snare.The operator communicated with the patient and finally withdrew the rest of the devices and finished the procedure.No other information was provided.
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 fractured portion of the subject device was left in the vessel and a snare was used in the procedure in order to retrieve the fragment.In addition, the patient had severely tortuous anatomy which may have contributed to the event.Based on the information provided, it is most likely that the subject device stent became dislodged from the device itself due to anatomical or procedural factors encountered during the procedure which then resulted in the un-retrieved device fragment.An assignable cause of procedural factors will be assigned to the reported ' retriever fractured/broken during use', 'un-retrieved device fragments', and 'difficult/unable to withdraw retriever', 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.
Event or Problem Description
It was reported that the subject sent device (trevo xp) was used on one right mca (middle cerebral artery) aneurysm case.Punctured through right femoral artery and placed 8f codis guide catheter, sofia aspiration catheter, pro-18 microcatheter and synchro guidewire to build access and placed middle catheter and microcatheter to the location.Prepared to use a subject device syent.Checked it and flushed it normally and then delivered it into pro18 microcatheter.After it was placed to the location, deployed it and withdrew it normally.For the first time to withdraw, no thrombus was observed.So the operator delivered it to deploy again and when withdrawing the subject stent, big resistance was encountered and the subject stent could not be retracted.Tried several times the subject stent was separated and left it in the vessel and could not be taken out with a snare.The operator communicated with the patient and finally withdrew the rest of the devices and finished the procedure.No other information was provided.

• Brand Name: TREVO XP PROVUE 6MM X 25MM
• 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: 14438248
• Report Number: 3012931345-2022-00105
• Device Sequence Number: 5658724
• Product Code: NRY
• UDI-Device Identifier: 00815742001860
• UDI-Public: 00815742001860
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K143077
• 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): 09/15/2022

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: 02/02/2023
• Device Model Number: 90186
• Device Catalogue Number: 90186
• Device Lot Number: 0000058158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/21/2022
• Supplement Date Received by Manufacturer: 08/24/2022
• Initial Report FDA Received Date: 05/19/2022
• Supplement Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/03/2021
• 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: 8F CODIS GUIDE CATHETER; SOFIA ASPIRATION CATHETER; SYNCHRO GUIDEWIRE (STRYKER); TREVO PRO-18 MICROCATHETER (STYKER)
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 49 KG
• Patient Race: Asian