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	09/28/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the patient needed a right distal superficial femoral artery (sfa) to mild popliteal intervention.An atherectomy was done with a drug coated balloon (dcb) to mid pop to distal right sfa, and stent from mid to distal sfa.The access was a cut down to the right proximal sfa with a short 7 french sheath antegrade positioned.The vessel was 6 mm in diameter and 150 mm in length was needed.When the stent was deployed, the stent did not elongate.After deployment, it shortened.The stent length was not enough, and another misago stent was placed proximally.However, it was foreshortened also.The stent length was 100 mm.The doctor used a third stent to cover the length to the mid sfa.The stent was a zilver balloon expanding stent.The patient's vessel was fully opposed, and flow was not limited.Prior to the intervention the vessel was a chronic total occlusion (cto).The case was successful.The patient was in stable condition.The procedure was a successful intervention of right sfa.The artery of the lower extremity was not previously treated.The lesion treatment history was de novo.The right limb was diseased.The calcification was moderate.Tortuousness was mild.Tasc ii classification was type b.The lesion length was approximately 150 mm.The percentage of diameter stenosis was 100%.The reference vessel diameter was approximately 6 mm.The femoral artery ipsilateral, antegrade, and lesion treatment was performed pre-treatment was post-treatment.The event occurred intra-operative.There was no patient injury/medial or surgical intervention required.

• 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: 15668057
• Report Number: 2243441-2022-00025
• Device Sequence Number: 6462970
• Product Code: NIP
• UDI-Device Identifier: 04987350727749
• UDI-Public: 04987350727749
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2022
• Report Date (Section F): 10/25/2022

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: 12/31/2024
• Device Model Number: N/A
• Device Catalogue Number: SXR06150R
• Device Lot Number: 220114
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/28/2022
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LIGHTBOX OCT.; NAVICROSS.; PANTHERA ATHERECTOMY.; ZILVER STENT.
• Patient Sex: Female
• Patient Weight: 74 KG
• Date Report Sent to FDA: 10/25/2022