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

Catalog Number	SXR07150R
Medical Device Problem Codes	Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	03/07/2022
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the misago stent involved was advanced over an 014 viper wire after the vessel has been prepped with an atherectomy device and pre-dilated with a 6x150 balloon.The 7x150 misago was advanced down smoothly.The doctor unlocked the thumb wheel and started to roll it back slowly.After several clicks, the entire stent came outside of the body.The device started twisting and torquing very badly, the doctor had stopped and asked what was wrong with the stent.The distal end of the stent was also moving back more than normal.The doctor was instructed to keep deploying.After the stent flowered open, the tension released on the stent, and it deployed.This was presumed to not be a good deployment and the doctor was not happy with it.The stent was shortened to about a length of 140 millimeters, this was known because the balloon was 150 millimeters post dilating the stent.The patient was in good condition.The procedure was a success.There was no patient injury/medical or surgical intervention required.Additional information was received on 09 mar 2022: the procedure performed was a superficial femoral artery (sfa) atherectomy/stent.The patient was in stable condition.Additional information was received on 22 mar 2022: the sfa was the blood vessel where the stent was attempted to be placed.The condition of the lesion was heavy calcium, but the vessel was prepped with atherectomy and angioplasty before placing the stent.The stent stayed within the proximal marker, but the distal end of the stent foreshortened while deploying.It is unsure if the outer catheter got stuck on the stent while sliding back, which caused the stent to fore shorten.This could have caused the energy build up which created the twisting and torquing on the catheter outside the body post dilation.A 150mm balloon length was used which is how it is known the 150mm stent was foreshortened to roughly 140mm.
Additional Manufacturer Narrative
Implanted date: device was not implanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the manufacturing record and the shipping inspection record of the involved product/lot number combination confirmed there was no problem in them.A search of the complaint file found no other report with the involved product code/lot number combination from other facilities.This product has a structure in which the stent self-dilates by turning 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 with the sliding part of delivery catheter trapped, the movement of the sliding part on the hand side is hindered and only the release wire is wound up.At that time, compressive force is applied to the proximal shaft located outside the patient's body, causing waviness, and the distal side (stent sheath) of catheter moves to the hand side.In addition, when the force for trapping the sliding part is larger than the force for pulling the sliding part toward the hand side, the force for pushing out the inner tube works, and the inner tube (contrast marker) moves forward.The stent deployed from the sliding part (stent sheath) is pushed out by the proximal marker on the inner tube shaft to apply compressive force and contract.The above may be prevented by properly holding the catheter.Simulation test results have showed the following: in the simulated blood vessel of lower extremity model, a contralateral approach was performed with a factory-retained destination 6fr 45cm, and the distal end of destination was positioned at iliac.Then, a factory-retained misago was inserted to the sfa along our guidewire, and the sliding part (stent mount part) of misago was trapped through the simulated tube with forceps.Only the handle of misago was held, not the catheter of misago, and started clicking on the thumbwheel.At the time of 7 clicks, waviness occurred on the shaft located outside the body.With 18 clicks, the stent deployment started.At that time, the inner tube shaft was advancing from the sliding part (stent sheath).Continued clicking to deploy the stent to the full length.As a result, a part of the stent was compressed and became dense and contracted.Based on the investigation result and the simulation test result, the following factors were inferred.However, since the actual product was not returned, the cause of occurrence could not be clarified.I) the sliding part (stent mount part) of actual product was trapped by some hard object (e.G.Calcified lesion).Therefore, it was hindered from pulling the sliding part toward the hand side, compressive force was applied to the shaft outside the patient's body, and waviness occurred.Ii) in addition, it was likely that waviness of the shaft progressed remarkably due to insufficient holding of the delivery catheter, and the distal side (stent sheath) of catheter moved to the hand side.Iii) since the trap hindered the sliding part from moving toward the hand side, the force to push out the inner tube worked, and the inner tube (contrast marker) advanced.At that time, it was likely that the deployed stent was pushed out by the proximal marker on the inner tube shaft and contracted.Ashitaka factory manufacturing process is always continuing diligence in maintaining the product quality by performing following inspections: i) after the stent processing, 100% inspection is performed with an imaging device to assure that there is no deformation or fracture in the stent strut.Ii) after the stent processing, 100% inspection is performed with an imaging device for the width and thickness of the stent strut.Iii) after mounting the stent on the delivery catheter, the length of stent is measured on 100% basis to assure the length of stent.Iv) after mounting the stent on the delivery catheter, 100% visual inspection is performed to assure that there is no overlapping, deformation or fracture in the stent strut.In addition, it was also confirmed that there is no kink or crush in the sliding part and the shaft.V) with a load measuring device, the load when releasing the stent are measured on 100% basis, and it is confirmed that there is no anomaly in the release resistance.For future use, directions for use found in the ifu of this product should be noted, as appropriate: "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 and do not move the delivery catheter at the operator side of the intermediate shaft." (b)(4).

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: stephanie handy ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 13998845
• Report Number: 9681834-2022-00046
• Device Sequence Number: 17573154
• Product Code: NIP
• UDI-Device Identifier: 04987350727787
• UDI-Public: 04987350727787
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/04/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: SXR07150R
• Device Lot Number: 200717
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 04/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/17/2020
• 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: 014 VIPER WIRE
• Patient Sex: Unknown