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	Stretched (1601)
Health Effect - Clinical Code	Calcium Deposits/Calcification (1758)
Date of Event	09/27/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the doctor had antegrade access on the left femoral artery with a 6 french 10 centimeter pinnacle sheath when he attempted to stent the distal superficial femoral artery (sfa) with a misago device involved.The physician rolled the wheel on the delivery system; however, the stent was not deploying.After manipulation of the system forward and backwards it started to deploy.The stent started to scrunch up; therefore, slight tension was pulled on the delivery system as the stent deployed.This caused the stent to elongate about 20-30 millimeters.The entire sfa was heavily calcified.The estimated blood loss was less than 250cc's.The patient was in stable condition.The procedure was successful.The event occurred intra-operative.There was no patient injury/medical or surgical intervention required.Additional information was received on 05 oct 2022: another stent was placed in addition (within) to the elongated stent.

• 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: 15638612
• Report Number: 2243441-2022-00026
• Device Sequence Number: 5677498
• Product Code: NIP
• UDI-Device Identifier: 04987350727749
• UDI-Public: 04987350727749
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/20/2022
• Report Date (Section F): 10/20/2022

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/27/2022
• Device Age: 26 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/20/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 58 KG
• Date Report Sent to FDA: 10/20/2022