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 03/01/2024

Event Type  Injury  

Manufacturer Narrative

A1: patient identifier: requested, not available.A2: age or date of birth: requested, not available.A3a: sex: requested, not available.A3b: gender: n/a.A4: weight: requested, not available.A5: ethnicity: requested, not available.A6: race: requested, not available.D4: lot #: requested, unknown.D4: expiration date: unknown, as the involved product lot # was unknown.D4: udi: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.H4: device manufacture date: unknown, as the involved product lot # was unknown.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The involved production lot was unknown, regarding the involved product code, review of the manufacturing record and the shipping inspection record of the production lots for the past three years (equivalent to the expiration period) from the date of occurrence was performed, and no anomaly was found.Since the involved production lot was unknown, a search of the complaint file regarding the involved product code for the past three years (equivalent to the expiration period) was performed, and no other similar report from other facilities was found.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.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 our guidewire.Pulling force was applied while the stent was in the middle of being released.As a result, the stent was elongated with wider spaces between the struts.Cause of occurrence/conclusion; based on our past knowledge, it was thought possible that tensile force toward the proximal side was applied to the actual sample while the stent was being released, which resulted in the elongation of stent; however, the cause of occurrence could not be clarified.Relevant instructions for use (ifu) reference: 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.·do not pull the delivery system tight during stent deployment.(the stent can become elongated during deployment.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).

Event Description

The user facility reported that the involved misago 8-100 device was placed after a percutaneous old balloon angioplasty (poba), and after that, the stent was found elongated, so post dilation with senri 7-4 was added to finish the procedure.The stent was pulled with tension during alignment before being placed.Though no health hazard to the patient, the stent was elongated and additional treatment with competitor's device was required.The procedure outcome was completed successfully.The event occurred intra-operative.The final patient impact was not harmed.

• 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: 19009008
• MDR Text Key: 338981219
• Report Number: 9681834-2024-00037
• 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: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2024
• 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-LMA08X0RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other