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

Catalog Number	SXR07150R
Medical Device Problem Codes	Break (1069); Activation Problem (4042)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the involved misago device was used to treat a heavily diseased superficial femoral artery (sfa) from the brachial artery.The doctor had to cross through an aortic graft and a balloon expandable stent in the ostial sfa.When the doctor rolled back the wheel on the misago, the shaft of the stent started to curl up/spiral, but the stent had not started to flower.The doctor pulled the whole stent back.The tip of the stent with the distal markers stayed in the sfa, but the rest of the device was stuck in the destination 6 fr 90cm sheath.The patient was in stable condition.There was no patient injury, medical/surgical intervention required.Additional information was received on 03 mar 2022: the tip was not removed from the patient.There was no blood loss.The procedure was not completed successfully.

• 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: 13806894
• Report Number: 2243441-2022-00003
• Device Sequence Number: 4467462
• Product Code: NIP
• UDI-Device Identifier: 04987350727787
• UDI-Public: 04987350727787
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 03/17/2022
• Report Date (Section F): 03/17/2022

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: 05/31/2023
• Device Catalogue Number: SXR07150R
• Device Lot Number: 200604
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 02/23/2022
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2022
• 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: BALLOON EXPANDABLE STENT; DESTINATION 6 FR 90CM SHEATH
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/17/2022