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

Model Number	SXR06150R
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Thrombosis/Thrombus (4440)
Date of Event	06/04/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that post-deployment of two misago stents (6x150 units) in the superficial femoral artery (sfa), the proximal stent was considered to be crimped, with the edges of the stent appearing inward.The distal stent, also 6x150 (same lot number), was foreshortened upon deployment.After deployment of both stents, there was no flow through the stents, and the patient began to show clots throughout the leg.The physician had difficulty cannulating the proximal stent due to the edges appearing crimped.The type of procedure performed was an sfa peripheral angiogram.There was no blood loss.The reported event did result in patient injury and required medical or surgical intervention.The event occurred intra-operatively.Estimated blood loss was none.The patient was admitted to the operating room for possible clot aspiration or bypass.Additional information received on 10 jun 2025: indicated that in additional surgical/medical procedures performed after the stent shrinkage, the lysis catheter was inserted in a subsequent procedure.The patient is stable and doing well according to the physician.

• 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: 22391638
• Report Number: 2243441-2025-00032
• Device Sequence Number: 9069551
• Product Code: NIP
• UDI-Device Identifier: 04987350727749
• UDI-Public: (01)04987350727749(17)270731(10)240807
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2025
• Report Date (Section F): 07/02/2025

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 Model Number: SXR06150R
• Device Catalogue Number: SX*FMA06X5RN
• Device Lot Number: 240807
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/05/2025
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• 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: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 07/02/2025