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 07/21/2023

Event Type  malfunction  

Event Description

The user facility reported that the doctor deployed the misago in the superficial femoral artery (sfa).When deploying he felt a little resistance after about 1/2 way through deploying.Under fluoroscopy it looked like it was bunched up, but as he continued to scan, he realized that the proximal end was nearly in the iliac.Our assumption was that it may have gotten caught on the end of a catheter or something that caused it to elongate.The patient condition was good.The outcome of the procedure was good.Additional information was received on 27jul2023: additional devices were used to complete the procedure.The patient was stable.

Manufacturer Narrative

The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.1.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.2.A search of the complaint file found no other similar report of the product with the involved product code/lot# from other facilities.3.Udi no.:(b)(4).4.Product structure: 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 proximal side.When the stent release is performed while the sliding part of delivery catheter is trapped, the movement of the sliding part on the proximal side is hindered, which makes it difficult to deploy the stent.At that time, compressive force is applied to the proximal shaft located outside the patient's body, and waviness is caused.Of note, the above may be prevented by properly holding the catheter.In the above state, when the operation of pushing and pulling the delivery catheter is performed, the force that has been compressed is released, the force that pushes out the inner shaft works, and the inner shaft (contrast marker) moves forward.The stent deployed from the sliding part (stent sheath) is pushed out by the proximal marker on the inner shaft, exposed to compressive force, and constricts.During stent deployment, when pulling force is applied to the delivery catheter to the proximal side, an opening begins to occur in the deployed stent strut starting from the point where it is compressed at the stenosis part.Continued application of pulling force causes the stent to be implanted with elongated stent struts.Based on our past knowledge, it was inferred that this event may have occurred by the following mechanism.However, since the actual product was not returned, it was not possible to clarify the cause of occurrence.(1) the sliding part of actual product (stent mount section) was trapped by some hard object (e.G.Calcified lesion).This prevented the sliding part from being pulled to the proximal side, making it difficult to deploy the stent.At that time, compressive force was applied to the proximal shaft located outside the patient's body, and waviness occurred.(2) due to insufficient holding of the delivery catheter, operability declined as the rotation of thumbwheel was continued, and the waviness of shaft progressed.(3) in the state of (2), the operation of pushing and pulling the delivery catheter was performed.Due to this, the force that had been compressed was released, the force that pushed out the inner shaft worked, and the inner shaft (contrast marker) moved forward.Then, the stent deployed from the sliding part (stent sheath) was pushed out by the proximal marker on the inner shaft, exposed to compressive force, and constricted.As a result, the stent looked like it was bunched up under fluoroscopy.(4) while the stent was being deployed in (3), pulling force was applied to the delivery catheter to the proximal side and the stent struts started to open from the point where it was compressed at the stenosis part.(5) as a result of continuing application of pulling force in the state of (4), the stent was implanted with the struts in elongated state.Ashitaka factory manufacturing process has been making efforts in maintaining the quality of the product by performing following inspections.- after the stent processing, 100% inspection is performed by an imaging device to assure that the stent strut is not deformed or fractured.- after the stent processing, the width and thickness of the stent strut are inspected on 100% basis by an imaging device.- after the stent is mounted on the delivery catheter, the length of stent is measured on 100% basis to assure it.- after the stent is mounted on the delivery catheter, 100% visual inspection is performed to assure that there is no anomaly such as overlap, deformation or fracture of the stent strut.It is also confirmed that there is no kink or crush in the sliding part or the shaft.- the load at the time of stent release is measured on 100% basis by the load measuring device to confirm that there is no anomaly in the release resistance.Ifu reference: [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 and do not move the delivery catheter at the operator side of the intermediate shaft.[directions for use 3-6 precautions] - do not pull the delivery system tight during stent deployment.(the stent can become elongated during deployment.) terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

• 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: 17600352
• MDR Text Key: 321737947
• Report Number: 9681834-2023-00173
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04987350727626
• UDI-Public: 04987350727626
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/22/2023

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: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: SXR07100R
• Device Lot Number: 201001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2023
• Initial Date FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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
• Patient Age: 65 YR
• Patient Sex: Male