MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 03/30/2023

Event Type  malfunction  

Event Description

The user facility reported that an attempt was made to use the misago product involved for a crossover procedure.At the time of deployment, the click resistance was unusually hard, and the stent was not fully deployed.Although it continued clicking, the deployment did not start even after approximately ten (10) clicks.It was thought that the stent might pop out suddenly; therefore, it was put back into the guiding sheath once, and the stent popped out at that moment.The lesion was accompanied by calcification and tortuosity of the iliac.Therefore, it was not possible to determine whether the sliding part was hindered or whether the incident was caused by the product.When another new product was used, it was able to deploy successfully.A replacement product was used, and the case was successfully completed.The actual product was discarded according to the hospital rules.There was patient injury/medical or surgical intervention.The procedure was completed successfully.No substance remained in the patient's body (retrieved).

Manufacturer Narrative

Udi: n/a.As this product code is not exported to the us market.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual sample was discarded by the involved facility.Review of the manufacturing record and the shipping inspection record of the product with the involved product code/lot number confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report of the product with the involved product code/lot number.Product structure and mechanism of occurrence.This product has a structure in which the stent self-dilates by rotating the thumbwheel (winding up the release wire connected to the sliding part) and pulling the sliding part toward the hand side.If the stent is released while the sliding part of delivery catheter is trapped in a calcified lesion, etc., the sliding part will be hindered from being pulled toward the hand side, and the stent may not be deployed with a normal number of clicks.In addition, since only the release wire is to be wound at that time, compressive force is applied to the shaft and waviness is occurred.In addition, when the force that traps the sliding part is greater than the force that pulls the sliding part toward the hand side, a force that pushes the inner shaft acts, and the inner shaft (contrast marker) attempts to move forward.This can cause the stent to be pushed out by the proximal marker on the inner shaft.The above may be prevented by properly holding the catheter.The following simulation tests were performed to confirm the above mechanism of occurrence.Simulation test 1: in the simulated lower limb blood vessel model, a contralateral approach was taken with destination 6 french.Then, factory-retained misago was advanced along a factory-retained 0.035-inch guidewire to the left superficial femoral artery (sfa).An attempt was made to release misago.At 8 clicks, the stent began to deploy, and at 30 clicks, the stent was fully deployed.Simulation test 2: in the same test system as simulation test 1, a factory-retained misago was inserted to the left sfa.Then, the simulated blood vessel tube was tightened with a restraining band to narrow the inner diameter and trap the sliding part (stent mount section) of misago.An attempt was made to release misago.At 7 clicks, the click became heavy.At 8 clicks, compressive force was applied to the proximal shaft outside the body, causing waviness.In addition, the inner shaft advanced, and the stent began to partially come out from the distal end of sliding part.However, the stent had not yet been deployed.Heaviness of the click increased each time the click was repeated, and the stent further came out from the distal end of sliding part at 10 clicks.However, the stent had not yet been deployed.An attempt was made to remove misago.The stent began to deploy when it was withdrawn to the distal end of destination.It was inferred that this was because the part of stent coming out at the simulated stenosis or at the distal end of destination was caught at the time of removal, and removal force was applied to misago in that state.As a result, the stent further came out from the sliding part and deployed.From simulation test 1 and 2, it is inferred that if the sliding part of misago is trapped in a calcified lesion, etc., the stent will not deploy with the usual number of clicks.As a possible cause of this case, following factors were inferred.Since the sliding part of actual sample was trapped by calcified lesions, etc., the movement of sliding part to the hand side was hindered, and the stent could not be deployed with the usual number of clicks.In addition, when clicking, since the release wire made it difficult to pull the sliding part to the hand side, the click became heavy.In the above condition, the movement of sliding part to the hand side was hindered.Therefore, compressive force was applied to the shaft of actual sample, causing waviness on the shaft.In addition, the recoil acted to push the inner shaft, and the inner shaft (contrast marker) tried to move forward.As a result, the stent was pushed out by the proximal marker on the inner shaft, and after approx.10 clicks, the stent was partially coming out from the distal end of sliding part, though it had not yet been deployed.An attempt was made to remove the actual sample.It was found that the stent partially coming out from the sliding part was caught at the calcified lesion and the distal end of destination.In that state, removal force was applied to the actual sample.As a result, stent came out further from the sliding part, leading to deployment.Relevant instructions for use (ifu) reference: "precautions pre-dilatation of the target vessel is recommended." "directions for use 3-6 to maintain the position of the delivery catheter while rotating the thumbwheel, grip the delivery catheter by hand at the operator side (proximal) of the intermediate shaft.Do not move the delivery catheter at the operator side of the intermediate shaft." "directions for use 4-3 precautions deploy the stent completely, even if the delivery catheter bends and corrugates.(removal of the delivery catheter prior to full deployment of the stent could cause the stent to deploy in an unexpected site.)".(b)(4).

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16815158
• MDR Text Key: 314015156
• Report Number: 9681834-2023-00081
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/26/2023

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: 04/30/2023
• Device Model Number: N/A
• Device Catalogue Number: SX-LMA0760RN
• Device Lot Number: 200527
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2023
• Initial Date FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/27/2020
• 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: JUPOTER S6.; PARENT SELECT.