MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION MISAGO; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 05/11/2023

Event Type  Injury  

Manufacturer Narrative

The actual sample was discarded by the involved facility.Record review: review of the manufacturing record and the shipping inspection record of the product with the involved product code/lot# confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report of the product with the involved product code/lot# from other facilities.Product structure and mechanism of occurrence: 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.If the stent is released while the sliding part of delivery catheter is trapped, movement at the hand side of sliding part is hindered, and only the release wire is wound.This applies compressive force on the proximal shaft, which is located outside the patient's body, causing waviness.In addition, when the force that traps the sliding part is greater than the force that pulls the sliding part toward the hand side, a force that pushes the inner shaft acts, and the inner shaft (contrast marker) moves forward.As a result, the stent deployed from the sliding part is pushed out by the proximal marker on the inner shaft and compressive force is applied, leading to a contraction (shortening).The above may be prevented by properly holding the catheter.As a possible cause of this case, following factors were inferred.However, since the actual sample was not returned, the cause of occurrence could not be clarified.· the sliding part of actual product (stent mount section) was trapped by some hard object (e.G.Cto lesion).This prevented the sliding part from being pulled to the hand side.· at that time, due to insufficient holding of the delivery catheter, compressive force was applied to the shaft located outside the patient's body, and waviness was occurred.· since the movement at the hand side of sliding part was hindered by trapping, a force that pushes the inner shaft acted, and the inner shaft (contrast marker) moved forward.At that time, the deployed stent was pushed out by the proximal marker on the inner shaft, and part of the stent contracted (shortened).Relevant instructions for use (ifu) reference: "3-6to 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 deliverycatheter 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).

Event Description

The user facility reported that the involved product was used in the chronic total occlusion (cto) at the left external iliac artery (eia).The puncture sites were right radial and left femoral.When this product was delivered from the middle left femoral and was placed, the shaft was pulled forward and the stent was shortened.An additional stent was placed and the procedure was successfully completed.The procedure was completed successfully.There was no piece of the product that remained in the patient's body.Serious injury: based on the occurrence situation, the patient was not harmed.However, the stent contracted during release, and placement of an additional stent was needed to cover its length.

• Brand Name: MISAGO
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 17091073
• MDR Text Key: 316849553
• Report Number: 9681834-2023-00109
• 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: 06/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SX-LMA0880RN
• Device Lot Number: 220822
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/22/2022
• 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