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

Model Number N/A

Device Problems Stretched (1601); Physical Resistance/Sticking (4012); Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 10/02/2023

Event Type  Injury  

Manufacturer Narrative

D4: udi: n/a as this product code is not exported to the us market.D6b: explanted date: device was not explanted.Since the actual sample was not returned, following investigation was performed.A review of the manufacturing record and the shipping inspection record of the product with the involved product code/lot number 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 number.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 with the sliding part of delivery catheter trapped in a calcified lesion, the sliding part is hindered from being pulled toward the hand side, and the stent may not deploy with the normal number of clicks.At that time, only the release wire is attempted to be wound.Therefore, compressive force is applied to the shaft, causing waviness.As a possible cause of this case, the following mechanism was inferred.However, since the actual sample and the detailed circumstances of occurrence could not be confirmed, it was not possible to clarify the cause of occurrence.Since the sliding part of actual product was trapped by some object such as a calcified lesion, the movement of sliding part to the hand side was hindered, and the stent could not be deployed with the normal number of clicks.When the actual product was removed, the guidewire coming out of the exit port was deflected toward the aorta side, and it could not be removed.As a cause of deflection of the guidewire, it was inferred that the guidewire was pushed in with the distal end of guidewire trapped.However, since the details of circumstances were unknown, the cause of occurrence could not be clarified.Relevant ifu reference: "directions for use 4-3 precautions deploy the stent completely, even if the delivery catheter bends and corrugates.(removal of the delivery catheter prior to full deployment of the stent could cause the stent to deploy in an unexpected site.)" "if the stent does not start to deploy when the thumbwheel is rolled back, if no corrugations can be seen in the delivery catheter, stop rolling the thumbwheel, observe using high-resolution fluoroscopy, and then carefully remove the stent system.(the stent system could become unrecoverable.)" terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.

Event Description

The user facility reported that an approach was performed from the left arterial tibial artery (ata), and the lesion from the right external iliac artery (eia) to the common iliac artery (cia) was treated.Using a 14 wire, the first 7x60 misago was placed in the eia without any problem.When the second product was attempted to be advanced to the lesion, it was unable to be deployed.It was confirmed that the 14 wire was looped inside the aorta, and an attempt was made to take the deflection of the shaft of the 14 wire.However, the stent could not be pulled, and the deflection could not be removed at all.The stent got stuck and was unable to be deployed.Then, an attempt was made to remove it from the patient's body using a guiding sheath.However, the misago and the delivery system completely got stuck in the patient's body.As a result, the patient was transported to another hospital for surgical a procedure.The stent was scheduled to be removed with a surgical procedure; however, the stent was dilated with a medical procedure and was placed close to the target site.The delivery catheter was successfully removed.The placed stent was elongated.The stent could not be deployed.A medical procedure was performed to evade getting completely stuck inside the patient's body.The patient was harmed; however, not seriously.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• 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: 18011791
• MDR Text Key: 326619789
• Report Number: 9681834-2023-00209
• 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: 10/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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-LMA0860RN
• Device Lot Number: 201112
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 10/26/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2020
• 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