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

Catalog Number	SXR06150R
Medical Device Problem Code	Collapse (1099)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/03/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the 6mm misago stent collapsed in the common iliac.They were under the impression the doctor was placing in the sfa.The physician had to put a vbx stent in its place.They did a cut down on the left groin and restent.The procedure was successful.The patient's condition was stable, and they went home.The artery of the lower extremity was not previously treated.Lesion: left diseased limb; location sfa popliteal other cia.Calcification was moderate.Tortuousness was mild.Vessel diameter approximately (6 mm).Access site: other axillary.Lesion treatment history: post-dilatation: yes; pre-dilation: no.Additional information was received on 19mar2021.It was a r2p case.

• 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: 11618818
• Report Number: 2243441-2021-00012
• Device Sequence Number: 11816227
• Product Code: NIP
• UDI-Device Identifier: 04987350727749
• UDI-Public: 04987350727749
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 04/06/2021
• Report Date (Section F): 04/06/2021

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: 06/30/2022
• Device Catalogue Number: SXR06150R
• Device Lot Number: 190711
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 03/12/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/16/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2021
• 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: 6FR SLENDER DESITNATION
• Outcome Attributed to Adverse Event: Required Intervention
• Date Report Sent to FDA: 04/06/2021