MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PRO 14 MICROCATHETER 157CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number	90231
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/17/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is 1 of 3 report.The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the thrombus recovery procedure for mca lesions, the physician used an access catheter and a microcatheter to successfully deliver a stent retriever.However, the blood clots remained, the physician used a reperfusion catheter in combination with the subject microcatheter to access the treating site but could not cross the region.Therefore, both devices were withdrawn.The physician then reattempted to approach the aneurysm by combining two catheters but was unsuccessful.The physician gave up treatment and it was reported that the procedure was not completed successfully.The subject catheter fragments were noted in the peripheral area in the postoperative ct imaging.The location of catheter fragments are unknown for the specific position.No further information is available.
Additional Manufacturer Narrative
¿ h4 manufacturing date ¿ added.¿ h3 device evaluated by mfg ¿updated.¿ h3 summary attached - updated.¿ d4 expiration date - added.¿ d10/h3 product available to stryker ¿ updated.¿ d10 returned to manufacturer on ¿updated.There are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the catheter hub was intact.The catheter tip was intact.The catheter shaft was kinked and the catheter was intact.Functional testing was not required.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.As per the additional information continuous flush was maintained throughout the procedure.The catheter shaft was found to be kinked which may have caused issues reaching the target vessel.An assignable cause of procedural factors will be assigned to the reported device difficulty engaging target vessel and catheter damaged as well as the as analysed catheter shaft kinked/bent, as this complaint 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 factors during use.The as reported un-retrieved device fragments will be assigned not confirmed as no fragments were detached from the subject microcatheter.
Event or Problem Description
It was reported that during the thrombus recovery procedure for mca lesions, the physician used an access catheter and a microcatheter to successfully deliver a stent retriever.However, the blood clots remained, the physician used a reperfusion catheter in combination with the subject microcatheter to access the treating site but could not cross the region.Therefore, both devices were withdrawn.The physician then reattempted to approach the aneurysm by combining two catheters but was unsuccessful.The physician gave up treatment and it was reported that the procedure was not completed successfully.The subject catheter fragments were noted in the peripheral area in the postoperative ct imaging.The location of catheter fragments are unknown for the specific position.No further information is available.

• Brand Name: TREVO PRO 14 MICROCATHETER 157CM
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 12332369
• Report Number: 3012931345-2021-00133
• Device Sequence Number: 4454506
• Product Code: DQO
• UDI-Device Identifier: 00815742002317
• UDI-Public: 00815742002317
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K131437
• 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): 12/24/2021

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/11/2022
• Device Model Number: 90231
• Device Catalogue Number: 90231
• Device Lot Number: 40951
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/20/2021
• Supplement Date Received by Manufacturer: 11/30/2021
• Initial Report FDA Received Date: 08/17/2021
• Supplement Report FDA Received Date: 12/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/13/2020
• 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: AXS CATALYST 6 MICROCATHETER (STRYKER); PENUMBRA 3 MAX CATHETER (PENUMBRA); PENUMBRA 4 MAX CATHETER (PENUMBRA); TREVO NXT PROVUE RETRIEVER (STRYKER); TREVO TRAK 21 MICROCATHETER (STRYKER); AXS CATALYST 6 MICROCATHETER (STRYKER); PENUMBRA 3 MAX CATHETER (PENUMBRA); PENUMBRA 4 MAX CATHETER (PENUMBRA); TREVO NXT PROVUE RETRIEVER (STRYKER); TREVO TRAK 21 MICROCATHETER (STRYKER)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown