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

Model Number SX*FMA07X5RN

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2020

Event Type  malfunction  

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 product code/lot# combination was conducted with no findings.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 Description

The user facility reported that the doctor saw foreshortening of he involved r2p misago stent post dil.There was no patient injury, medical/surgical intervention required.The stent foreshortened by 1-2 cm.The procedure was a lower extremity revascularization.The patient's condition was stable.A different stent was used to successfully complete the procedure.It was implanted, just not the way it was intended.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: theresa mussaw ; reg. no. 2243441; 950 elkton blvd; elkton, md ; 2837866718
• MDR Report Key: 10104724
• MDR Text Key: 202391420
• Report Number: 9681834-2020-00086
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04987350727787
• UDI-Public: 04987350727787
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P140002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2022
• Device Model Number: SX*FMA07X5RN
• Device Catalogue Number: SXR07150R
• Device Lot Number: 190905
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/05/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 64