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

Model Number	SX*FMA0760RN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/12/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation- interventional cardiologist.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.Ifu states: do not use in highly tortuous or highly calcified lesions and/or vessels proximal to the lesion which could prevent proper pre-dilatation.With no device return nor the cine image the exact cause of the reported restenosis about nine months after the stent was implanted cannot be definitively determined based on the available information.(b)(4).
Event or Problem Description
The user facility reported that the 7x60 misago was implanted on (b)(6) 2020 in the l common iliac.The patient became symptomatic and determined to be stenosed under fluoroscopy.They put a 7x37 ev3 visipro balloon expandable stent inside the misago.Within nine months, the stent stenosed requiring intervention.The patient's condition was stable.Re-stenting the left common iliac was successful.

• 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: 10859857
• Report Number: 9681834-2020-00232
• Device Sequence Number: 2635606
• Product Code: NIP
• UDI-Device Identifier: 04987350727589
• UDI-Public: 04987350727589
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: SX*FMA0760RN
• Device Catalogue Number: SXR07060R
• Device Lot Number: 181121
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/22/2020
• Initial Report FDA Received Date: 11/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 118