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

Model Number N/A

Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/27/2022

Event Type  Injury  

Event Description

The user facility reported that the misago device involved was used for endovascular treatment (evt).The procedure was performed on a serve tortuous lesion in the left superficial femoral artery (sfa) by climbing over the mountain through the puncture of the right femoral artery.After the balloon was dilated and the stent was placed, it was found that the stent was shortened.Since the lesion could not be covered due to this event, another stent was added.The tortuous section at the time of climbing over the mountain was tight, and the moving part at the time of stent placement hit that part.The resistance to be pulled when the device was placed was stronger than usual.The procedure was completed successfully.The final patient impact was not harmed.There was no patient injury or surgical intervention required.

Manufacturer Narrative

The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there were not any indications of anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination from other facilities.This product has a structure in which the stent self-dilates by rotating the thumbwheel (winding up the release wire connected to the sliding part) and pulling the sliding part toward the hand side.When the force for catching the sliding part is larger than the force for pulling the sliding part toward the hand side, the force for pushing out the inner shaft works, and the inner shaft (contrast marker) moves forward.The stent deployed from the sliding part (stent sheath) is pushed out by the proximal marker on the inner shaft to apply compressive force and is crimped.The above may be prevented by properly holding the catheter.As a possible cause of this complaint, the following factor was inferred.However, since the actual sample was not returned, the cause of occurrence could not be clarified.The sliding part (stent mount section) of actual sample was caught by the tortuous section at the time of climbing over the mountain.As a result, the sliding part was hindered from moving toward the hand side during stent release.Therefore, the force to push out the inner shaft worked, and the inner shaft (contrast marker) advanced.Due to this, the deployed stent was pushed out by the proximal marker on the inner shaft, and was crimped, resulting in the stent shortening.Relevant ifu reference: "directions for use 3-6 to maintain the position of the delivery catheter while rotating the thumbwheel, grip the delivery catheter by hand at the operator side (proximal) of the intermediate shaft and do not move the delivery catheter at the operator side of the intermediate shaft." 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).

• 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: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15594084
• MDR Text Key: 301716590
• Report Number: 9681834-2022-00203
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P140002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SX-FMA07X5RN
• Device Lot Number: 201106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2020
• 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 Outcome(s): Required Intervention