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

Catalog Number 90184

Device Problem Fracture (1260)

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

Event Date 10/19/2023

Event Type  malfunction  

Manufacturer Narrative

H3 other text : the device is not available to the manufacturer.

Event Description

It was reported that during ica (internal carotid artery) occlusion procedure, the operator placed guiding catheter and distal access catheter to make basic access and used distal access catheter to do aspiration from c2 beginning.Massive thrombus was taken out.When reached c7, this segment was not able to be aspirated clearly so the operator used a guidewire to bring microcatheter to pass the occlusion to reach mca (middle cerebral artery) m1 distal and then delivered the retriever (subject device).After deploying the retriever (subject device) and waited for 5 min, the operator advanced the distal access catheter to proximal of occlusion to aspirate and began to use retriever (subject device) to take the thrombus out.The operator withdrew the retriever (subject device) into distal access catheter and after it was completely pulled into distal access catheter it got stuck and could not be pulled any more.The operator continued to do aspiration and then withdrew the distal access catheter, retriever (subject device), and microcatheter as a whole system out of patient's body.However, the operator found only delivery wire was taken out and the stent was not taken out.He thought the retriever (subject device) was fractured inside the distal access catheter so used syringe to inject normal saline from tail of distal access catheter and massive thrombus was flushed out together with the retriever (subject device) from tip of distal access catheter.The retriever (subject device) core wire was found fractured.Continued the aspiration until the guiding lumen was clear.Checked under dsa (digital subtraction angiography) and found the vessel was clear.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

Event Description

It was reported that during ica (internal carotid artery) occlusion procedure, the operator placed guiding catheter and distal access catheter to make basic access and used distal access catheter to do aspiration from c2 beginning.Massive thrombus was taken out.When reached c7, this segment was not able to be aspirated clearly so the operator used a guidewire to bring microcatheter to pass the occlusion to reach mca (middle cerebral artery) m1 distal and then delivered the retriever (subject device).After deploying the retriever (subject device) and waited for 5 min, the operator advanced the distal access catheter to proximal of occlusion to aspirate and began to use retriever (subject device) to take the thrombus out.The operator withdrew the retriever (subject device) into distal access catheter and after it was completely pulled into distal access catheter it got stuck and could not be pulled any more.The operator continued to do aspiration and then withdrew the distal access catheter, retriever (subject device), and microcatheter as a whole system out of patient's body.However, the operator found only delivery wire was taken out and the stent was not taken out.He thought the retriever (subject device) was fractured inside the distal access catheter so used syringe to inject normal saline from tail of distal access catheter and massive thrombus was flushed out together with the retriever (subject device) from tip of distal access catheter.The retriever (subject device) core wire was found fractured.Continued the aspiration until the guiding lumen was clear.Checked under dsa (digital subtraction angiography) and found the vessel was clear.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.During visual inspection, the retriever coils were seen to be damaged, the retriever shaped section was seen to be damaged, the retriever shaped section was seen to be broken/fractured at the proximal end, and the insertion tool was not returned.A functional inspection was not carried out due to the damage noted to the device.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 'retriever core wire broken during use' was not confirmed, however the retriever shaped section was noted to be fractured.The reported 'retriever difficult/unable to go through catheter shaft' could not be replicated as functional testing was unable to be performed.The analysis results are consistent with the reported event.The device failed to meet specification when received, based on the damage noted.It was reported that the operator withdrew the retriever into the catheter and after it was completely pulled into the catheter, it got stuck and could not be pulled any more.The operator continued to do aspiration and then withdrew the whole system out of patient's body.However the operator found only delivery wire was taken out and the retriever was not taken out.He thought the retriever was fractured inside the catheter so used syringe to inject normal saline from tail of catheter and massive thrombus was flushed out together with the retriever from tip of the catheter.As per the additional information, the patients anatomy was moderately tortuous.The device was returned for analysis and it was confirmed that the retriever shaped section had fractured proximally, as opposed to the core wire as was reported, there was also damage noted to the distal end of the core wire coil adjacent o the fracture point.It is probable that the 'massive' thrombus caused difficulties when attempting to be retracted into and through the catheter, causing the retriever to fracture.An assignable cause of procedural factors will be assigned to the reported 'retriever core wire broken during use' and 'retriever difficult/unable to go through catheter shaft' and to the analyzed 'retriever coils damaged', 'retriever shaped section damage' and 'retriever fracture/broken during use', 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.

• 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: 18319041
• MDR Text Key: 330388225
• Report Number: 3012931345-2023-00256
• Device Sequence Number: 1
• Product Code: NRY
• 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: 02/09/2024

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: 90184
• Device Lot Number: 0000165803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2023
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 01/30/2024
• Supplement Dates FDA Received: 02/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/04/2022
• 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: 8F GUIDING CATHETER (NON-STRYKER); CATALYST 6 CATHETER (STRYKER); PRO18 CATHETER (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER)
• Patient Age: 59 YR
• Patient Sex: Male
• Patient Race: Asian