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 Codes	Fracture (1260); Stretched (1601)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/07/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that while deploying the misago stent in the mid to proximal superficial femoral artery (sfa), the stent stretched out and fractured in the middle.The stent also went back into the sheath and the doctor had to push it back out.This caused the stent to stretch out from the sfa through the common femoral.The stent did fracture in the mid-section.The patient was in stable condition.The procedure outcome was successful.There was no patient injury/medical or surgical intervention required.The event occurred intra-operative.Additional information received on (b)(6) 2022: the stent was fractured in the mid-section and remained in the patient's body.

• 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: 15191294
• Report Number: 2243441-2022-00023
• Device Sequence Number: 5542447
• Product Code: NIP
• UDI-Device Identifier: 04987350727749
• UDI-Public: 04987350727749
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 08/09/2022
• Report Date (Section F): 08/08/2022

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: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: SXR06150R
• Device Lot Number: 200715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 07/12/2022
• Device Age: 23 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2022
• 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: DESTINATION; WIRE
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 08/08/2022