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

Model Number	SXR06150R
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the physician was treating an occluded superficial femoral artery (sfa) stent in the right sfa via left common femoral access.A 7fr destination sheath was used.To treat the occluded stent, the physician placed a 6mm spiderfx wire into the popliteal artery and used jetstream.After plastying the artery, it was decided to extend the existing stents into the distal sfa with a 6mm x 150cm misago stent.This was done over the spider wire due to some clot seen in the artery.The misago stent was successfully deployed and plastied with a 6mm crosstella balloon.The physician decided to use a 5fr x 100cm glidecath to try and re-capture the spider filter wire because of the debris and clot believed to be in the basket.The physician was unable to completely capture the spider wire basket within the glidecath and attempted to pull the system through the stents partially uncaptured.It is believed that the spider wire filter basket caught the misago stent struts in two different places, causing the misago stent to bunch up and fold on itself.The physician was able to pass a 0.035 navicross past both mangled parts of the misago and stent open the misago with a 6mm x 100cm viabahn stent.The physician used ivus imaging post viabahn placement and deemed that the artery looked good, and no further intervention was needed.No hematoma or perforation of the artery was believed to have occurred due to the issue.The patient remained stable throughout, and the procedure was a success.The event occurred intra-operatively.The procedure performed was a right lower extremity (rle) angiogram with intervention.The reported blood loss was none.This was a temporary issue, with no injuries to the patient.Medical or surgical intervention requires the placement of a covered stent within the misago.Additional information was received on 12 may 2025: the physician accessed the left common femoral artery (cfa) and was treating the right sfa.

• 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: 22129205
• Report Number: 2243441-2025-00025
• Device Sequence Number: 7487436
• Product Code: NIP
• UDI-Device Identifier: 04987350727749
• UDI-Public: (01)04987350727749(17)261130(10)231220
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 06/02/2025
• Report Date (Section F): 06/02/2025

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: 231220
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/05/2025
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/02/2025
• 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 Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 06/02/2025