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

Model Number	SX*FMA06X2RN
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2020
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 product release decision control sheet of the product code/lot# combination was conducted with no findings.Product structure/cause of stent shrinkage; by rolling back the thumb wheel, the traction wires connected to the sliding part are spooled and the sliding part is pulled in the proximal direction, when the stent starts to get self-expanded.If the stent is deployed in the state where the sliding part is trapped, and if the trapping force exceeds the force to pull the sliding part in the proximal direction, the non-sliding part starts to move forward and accordingly, the inner shaft and the stent start to move forward.Due to this, the stent is subjected to a compressive force during deployment and starts to get shrunk.It is likely that when the actual sample was inserted into the vessel, its sliding part was trapped with a hard object, including a stenosed/calcified segment of the lesion.In this state, the stent was deployed.The inner shaft and the stent started to move forward and the deployed stent was subjected to a compressive force, resulting in its shrinkage.However, 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 r2p misago rx self-expanding peripheral stent was used during the procedure.The stent was used to cover a dissection post atherectomy with a csi device and pta with an 018 crostella r2p balloon.The misago 6x120 r2p stent was inserted to cover the dissection and gave good tissue overlap.When the stent was deployed, it was noticeably foreshortened under fluoroscopy.When they inserted post dilation, 018 crostella r2p 6x100 balloon was inserted to dilate the stent to 6, the balloon was noticeably almost the same size of the stent and there should have been more stent than balloon.The lesion length was approximately 40 mm and the percentage of diameter stenosis was 85%.The reference vessel diameter was approximately 5 mm.The site of access is the radial artery and the approach was retrograde.Pre and post dilatation were done.There was no patient injury, medical/surgical intervention required.The patient's condition was good.The procedure outcome 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: 9812344
• Report Number: 9681834-2020-00038
• Device Sequence Number: 2891282
• Product Code: NIP
• UDI-Device Identifier: 04987350727725
• UDI-Public: 04987350727725
• 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): 03/10/2020

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: 08/31/2022
• Device Model Number: SX*FMA06X2RN
• Device Catalogue Number: SXR06120R
• Device Lot Number: 190924
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2020
• Initial Report FDA Received Date: 03/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR