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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that a 6x100 misago was deployed in distal superficial femoral artery (sfa) area where some plaque dissection was present.Upon deployment the proximal end of the stent appeared to be crimped.This malformation of deployment was not flow limiting, however it was a concern for the doctor after placement.He further investigated and showed under intravascular ultrasound (ivus) that the fluoroscopy image was confirmed, and the top of the stent was crimped.The doctor was not satisfied with the stent and realigned the misago with a 6x40 zilver ptx stent.The artery of the lower extremity was not previously treated.Right superficial femoral artery (sfa) was diseased limb.Site of the puncture was the femoral artery contralateral via antegrade approach.The lesion length 100, with a 5mm vessel diameter.The patient was stable, and the procedure outcome was successful.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18239352
• Report Number: 2243441-2022-00035
• Device Sequence Number: 6983888
• Product Code: NIP
• UDI-Device Identifier: 04987350727541
• UDI-Public: 04987350727541
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/30/2023
• Report Date (Section F): 11/30/2023

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: 11/30/2022
• Device Model Number: N/A
• Device Catalogue Number: SXR06100R
• Device Lot Number: 191204
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 06/01/2022
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/02/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/30/2023
• 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: 11/30/2023