MAUDE Adverse Event Report: STRYKER NEUROVASCULAR-UTAH-SALT LAKE CITY TREVO PROVUE 4MM X 20MM; CATHETER, THROMBUS RETRIEVER

Model Number 90184

Device Problem Fracture (1260)

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

Event Date 02/21/2023

Event Type  malfunction  

Event Description

It was reported that during the right ica c6 acute occlusion procedure, physician delivered intermediate catheter to c4 and reached c6 under aspiration.Physician used the adapt technique to aspirate the thrombus, but the ica was still occluded.Using guidewire, the microcatheter was brought to right mca m2 and then deployed the subject stent retriever.The physician used the solumbra technique and retracted the subject stent retriever at the same time.However, resistance was felt when the subject stent retriever went into the tip of the intermediate catheter.The physician pulled the subject stent out from tail of intermediate catheter and found that the connection between stent and delivery wire was fractured.Took the stent out and confirmed that much thrombus was taken out.Then continued to use intermediate catheter to aspirate but middle of m1 to distal was still occluded.Then used a guidewire and microcatheter to bring intermediate catheter to m1 to aspirate with adapt technique.Finally, the vessel was clear and confirmed tici 3.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

The device is not available to the manufacturer.

Event Description

It was reported that during the right ica c6 acute occlusion procedure, physician delivered intermediate catheter to c4 and reached c6 under aspiration.Physician used the adapt technique to aspirate the thrombus, but the ica was still occluded.Using guidewire, the microcatheter was brought to right mca m2 and then deployed the subject stent retriever.The physician used the solumbra technique and retracted the subject stent retriever at the same time.However, resistance was felt when the subject stent retriever went into the tip of the intermediate catheter.The physician pulled the subject stent out from tail of intermediate catheter and found that the connection between stent and delivery wire was fractured.Took the stent out and confirmed that much thrombus was taken out.Then continued to use intermediate catheter to aspirate but middle of m1 to distal was still occluded.Then used a guidewire and microcatheter to bring intermediate catheter to m1 to aspirate with adapt technique.Finally, the vessel was clear and confirmed tici 3.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Manufacturer Narrative

There are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, functional testing as well as visual testing cannot be performed.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 reported event could not be confirmed, and it cannot be confirmed that the device met specification, as the device was not returned.It was reported that when the stent went into tip of intermediate catheter it felt resistance.The operator pulled the stent out from tail of intermediate catheter and found the connection between stent and delivery wire was fractured.Took the stent out and confirmed that much thrombus was taken out.Additional information states that the patient¿s anatomy was moderately tortuous.The retriever was pulled out from the body with the stent of the support wire.It is probable that the retriever experience in pulling the retriever/ clot back to the distal end of the intermediate catheter, causing the distal end of the retriever to separate from its core wire, however as the device was not returned for analysis, this cannot be definitively determined, therefore an assignable cause of undeterminable will be assigned to as reported "retriever fractured/broken during use' and 'retriever difficult/unable to go through catheter shaft.

• Brand Name: TREVO PROVUE 4MM X 20MM
• Type of Device: 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: 16687412
• MDR Text Key: 312767217
• Report Number: 3012931345-2023-00057
• Device Sequence Number: 1
• Product Code: NRY
• UDI-Device Identifier: 00815742001846
• UDI-Public: 00815742001846
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K120961
• 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: 06/14/2023

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 Expiration Date: 12/07/2023
• Device Model Number: 90184
• Device Catalogue Number: 90184
• Device Lot Number: 0000095346
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2023
• Initial Date FDA Received: 04/06/2023
• Supplement Dates Manufacturer Received: 05/23/2023
• Supplement Dates FDA Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/08/2021
• 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: AXS CATALYST 6 DISTAL ACCESS CATHETER (STRYKER).; SYNCHRO2 GUIDEWIRE (STRYKER).; TREVO PRO 18 MICROCATHETER (STRYKER).
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Race: Asian