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

Model Number N/A

Device Problem Stretched (1601)

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

Event Date 01/10/2024

Event Type  Injury  

Manufacturer Narrative

D4: udi: n/a at this product code is not exported to the us market.D6b: explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.History investigation: review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed there was no indication of anomaly in them.A search of the complaint file found no other similar report regarding the involved product code/lot number from other facilities.Product structure: this product has a structure in which the stent self-expands by turning the thumbwheel (winding up the release wire connected to the sliding part) and pulling the sliding part toward the proximal side.If the stent is released with the sliding part of delivery catheter trapped, the movement of the sliding part on the proximal side is hindered, making it difficult for the stent to deploy.At that time, only the release wire is wound up, and a compression load is applied to the base shaft located outside the body, causing undulation.At that time, only the release wire is wound up and thus compressive force is applied to the proximal shaft located outside the patient's body, causing waviness.In addition, the operability of the thumbwheel decreases because the force to trap the sliding part is larger than that to pull the sliding part toward the proximal side.The above situation can be prevented by properly holding the catheter.Simulation test: regarding the stent elongation, the following simulation tests were conducted in the past.In the simulated lower limb blood vessel model, a contralateral approach was taken with factory-retained destination 6fr 45cm, and the distal end of destination was positioned at the iliac.Then, a factory-retained misago was inserted to the sfa along a guidewire of ours.Simulation test i: pulling force was applied while the stent was being released.As a result, the stent was elongated with wider spaces between the struts.Simulation test ii: the simulated vascular tube was tightened with tie bands to narrow the lumen to simulate stenosis, and an attempt to deploy a factory-retained misago stent was performed.As a result, the stent was exposed to compressive force at the simulated stenosis and elongated with wider spaces between the struts.Cause of occurrence/conclusion: based on our past knowledge, it was inferred that the reported event was caused by the following factors.However, since the actual sample was not returned, the cause of occurrence could not be clarified.Pulling force was applied to the proximal side when the stent was being released.The stent was released while the destination and the stent were compressed in the lesion site.Relevant instructions for use (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.

Event Description

The user facility reported that they had a puncture from the right common femoral artery (cfa).Contralateral approach with destination 6fr.45cm.After the predilation, destination was crossed the lesion, and then they tried to place the stent by the way the destination was used like a protective sheath.They attempted to deploy the stent in the lesion site in a manner that the stent was protected (destination was pulled back while the stent was being deployed inside the destination).As a result, the stent was elongated.As the elongated part of the stent had turned to be coarse and residual stenosis image was observed, a s.M.A.R.T stent was overlapped so that the misago was fully covered.The procedure was completed with no problems with blood flow.There was no residue in the patient and the procedure was completed successfully.

• Brand Name: R2P MISAGO RX SELF-EXAPNDING 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 ; 4103927218
• MDR Report Key: 18667371
• MDR Text Key: 334850499
• Report Number: 9681834-2024-00004
• 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: 02/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SX-LMA0880RN
• Device Lot Number: 230718
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/18/2023
• 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 Outcome(s): Required Intervention