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

Catalog Number	SXR08080R
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the misago was used during the procedure.During an up and over peripheral intervention 6fr right sided access.When the stent was deployed in the left external iliac artery, it was noticed that the distal portion appeared irregular and crimped.It was relined with an 8x100 misago stent and the runoff appeared fine.The procedure was completed.The patient's condition was stable.There was no patient injury, medical/surgical intervention required.The artery was not previously treated.The left limb was diseased.The lesion length was approximately 60mm.The diameter stenosis was 80 percent.The approximate vessel diameter was 7mm.The location was other external iliac.The calcification was moderate.The tortuousness was mild.The site of access was femoral artery contralateral via antegrade.Lesion treatment history: both pre and post dilation.Additional information was received on 09apr2021.There was no injury to the patient.Additional information was received on 15apr2021.The distal end of the stent was irregular and crimped.An additional misago was placed to cover the damaged part.

• 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: 11738048
• Report Number: 2243441-2021-00015
• Device Sequence Number: 3832637
• Product Code: NIP
• UDI-Device Identifier: 04987350727688
• UDI-Public: 04987350727688
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/28/2021
• Report Date (Section F): 04/28/2021

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: 12/31/2021
• Device Catalogue Number: SXR08080R
• Device Lot Number: 190131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/07/2021
• Device Age: 21 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/08/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2021
• 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: 62 YR
• Patient Weight: 60
• Date Report Sent to FDA: 04/28/2021