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

Model Number	SX*FMA0860RN
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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 shipping inspection record of the product code/lot# combination was conducted with no findings.Ifu states: where post-dilatation is needed, use a dilatation catheter with a balloon shorter in length than the stent and an expansion diameter roughly consistent with the reference vessel diameter.After post-dilatation, perform angiography to confirm adequate expansion.Do not force the dilatation catheter if you feel any resistance during the procedure.(this could deform or move the stent, damage the site of deployment, and/or damage or break the dilatation catheter.) with no return of the actual device, the exact cause of the reported event cannot be definitively determined based on the available information.(b)(4).
Event or Problem Description
The user facility reported that the md placed the misago device in right external artery via contralateral approach from left femoral artery (lfa).A destination guiding sheath used with a glidewire advantage 035.Initial placement of gore vbx stent in the distal external artery via the right femoral artery access, followed by misago placement via lfa.Upon post dilation stent was noted to have separated.The patient's condition was stable.The procedure outcome was successful.There was no patient injury, medical/surgical intervention required; additional stent placed covering the misago stent.The artery of the lower extremity was not previously treated.Diseased limb: right; locations: other iliac; calcification: moderate; tortuousness: mild; tasc ii classification: type c; lesion length approximately(mm):40; % diameter stenosis: 75; reference vessel diameter approximately (mm): 7.Site of access/puncture and approach: femoral artery contralateral.Lesion treatment history: pre-dilatation: yes; post-dilatation: yes.

• 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: 10459817
• Report Number: 9681834-2020-00168
• Device Sequence Number: 3273952
• Product Code: NIP
• UDI-Device Identifier: 04987350727664
• UDI-Public: 04987350727664
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (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): 08/27/2020

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: 09/30/2022
• Device Model Number: SX*FMA0860RN
• Device Catalogue Number: SXR08060R
• Device Lot Number: 191016
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR