MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PRO 18 MICROCATHETER 150CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90238

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2024

Event Type  malfunction  

Event Description

It was reported that during a neurovascular procedure when the operator attempted to deliver the retriever stent through the subject microcatheter, the stent retriever could not be advanced past middle cerebral artery (mca) c5 segment.The operator withdrew the subject microcatheter and the stent out together to check and found that the inner wall ptfe liner of the subject microcatheter was peeled.The subject microcatheter was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

B1: adverse event/product problem ¿ corrected - no ¿product problem¿.H1: type of reportable event ¿ corrected - no ¿malfunction¿.There are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection: the distal 15cm section of the catheter was noted to be kinked/bent.Functional test: the catheter was flushed and blood exited.A 0.021" patency mandrel was advanced through the flushed microcatheter and friction was experienced to the distal end in the location of the kinked section.The returned trevo retriever was unable to be advanced as it was extensively damaged when removed from the rebar microcatheter.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 defect 'catheter ptfe (polytetrafluoroethylene) inner lining peeling' was not confirmed based on analysis of the device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use, there was no damage noted to the packaging prior to opening the packaging, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush was set up and maintained throughout the clinical procedure.Also additional information indicated the patients anatomy was severely tortuous which would have contributed to the event.The catheter shaft was found to be kinked.There was friction felt advancing the patency mandrel past the kinked section of the catheter.There was blood identified in the catheter shaft.There was no ptfe inner lining peeling identified during analysis.The damage to the catheter shaft most likely occurred due to the patients anatomy.The as reported 'catheter ptfe inner lining peeling' will be assigned not confirmed as there was no ptfe inner lining peeling identified during analysis.The as reported 'catheter difficulty advancing retriever' as well as the as analyzed 'catheter kinked/bent' and 'catheter shaft friction' will be assigned procedural factors 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 anatomical factors during use, the product performance was limited.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 Description

It was reported that during a neurovascular procedure when the operator attempted to deliver the retriever stent through the subject microcatheter, the stent retriever could not be advanced past middle cerebral artery (mca) c5 segment.The operator withdrew the subject microcatheter and the stent out together to check and found that the inner wall ptfe liner of the subject microcatheter was peeled.The subject microcatheter was replaced and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TREVO PRO 18 MICROCATHETER 150CM
• Type of Device: 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: 18984012
• MDR Text Key: 338765899
• Report Number: 3012931345-2024-00048
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00815742002386
• UDI-Public: 00815742002386
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K113260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/17/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: 90238
• Device Lot Number: 0000583277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/08/2024
• Initial Date FDA Received: 03/26/2024
• Supplement Dates Manufacturer Received: 04/16/2024
• Supplement Dates FDA Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: TREVO RETRIEVER (STRYKER).
• Patient Age: 38 YR
• Patient Sex: Male
• Patient Race: Asian