MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA R2P MISAGO; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	SXR07120R
Medical Device Problem Codes	Material Fragmentation (1261); Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Codes	Pain (1994); Foreign Body Embolism (4439); Reduced Blood Flow (4598)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility during a lower extremity angiogram with intervention via contralateral femoral access, a physician successfully deployed a 7mm x 150cm misago stent in the superficial femoral artery (sfa) using a.035 rosen wire.A second stent, a 7mm x 120cm misago, was then prepared for implantation.According to the technologist, the stent was flushed with a syringe prior to use.Upon initiating deployment by rolling the wheel on the delivery system, the proximal shaft of the misago delivery system bent or kinked at a 90-degree angle at the strain relief of the handle, which prevented full deployment of the stent.The physician attempted to retrieve the partially deployed stent, but it began to fragment within the patient.The sheath had to be removed due to the compromised stent.Wire access was maintained, and a new sheath was introduced.A fragment of the stent was located within the tissue tract at the arteriotomy site and was successfully removed before the new sheath was placed.The physician proceeded to perform angioplasty on the sfa and deployed a protege stent.However, a fragment of the misago stent remained lodged in the iliac artery.The technologist reported that the physician may have performed angioplasty on the iliac artery to secure the stent fragment and prevent distal migration.Due to unsatisfactory pedal pulses post-procedure, the physician planned to take the patient to the operating room (or).At the time the event was reported, the patient had not yet been taken to the or.The estimated blood loss during the procedure was less than 250cc.The event resulted in the removal of the compromised stent, placement of a new stent, and retention of a stent fragment in the iliac artery.The vascular surgeon intended to bring the patient to surgery the following day.

• Brand Name: R2P MISAGO
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• MDR Report Key: 22162298
• Report Number: 2243441-2025-00022
• Device Sequence Number: 17997596
• Product Code: NIP
• UDI-Device Identifier: 04987350727763
• UDI-Public: (01)04987350727763(17)250930(10)221006
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: SXR07120R
• Device Catalogue Number: SX*FMA07X2RN
• Device Lot Number: 221006
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 05/08/2025
• Device Age: 34 MO
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown