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

Model Number	SX*FMA07X0RN
Medical Device Problem Code	Inadequacy of Device Shape and/or Size (1583)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2020
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.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 become shrunk.A review of the device history record and the shipping inspection record of the involved product code/lot# combination was conducted with no findings.When the actual sample was inserted into the vessel, its sliding part was trapped with a hard object, including a calcified segment of the lesion.In this state, the stent was deployed.As a result, 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.Terumo medical products (tmp) (importer) registration no.(b)(4).Is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.(b)(4).
Event or Problem Description
The user facility reported that the involved r2p misago was used during the procedure; and the doctor stated that it foreshortened.He had to use a second misago stent to complete the case.The procedure was completed.The patient's condition was stable.There was no patient injury, medical/surgical intervention required.Additional information was received on (b)(6).2020, the procedure taking place at the time was a revascularization of lower extremity.The procedure was completed successfully with the second 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: 10223438
• Report Number: 9681834-2020-00115
• Device Sequence Number: 3093404
• Product Code: NIP
• UDI-Device Identifier: 04987350727626
• UDI-Public: 04987350727626
• 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): 07/02/2020

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*FMA07X0RN
• Device Catalogue Number: SXR07100R
• Device Lot Number: 181127
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2020
• Initial Report FDA Received Date: 07/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 96