MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT; 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 05/08/2023

Event Type  malfunction  

Manufacturer Narrative

D4: udi: n/a as this product code is not exported to the us market.D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual sample was discarded by the involved facility.Review of the manufacturing record and the shipping inspection record of the involved product code/lot number combination confirmed that there was not any anomaly in them.A search of the complaint file found no other similar report with the involved product code/lot number combination.The product is designed to release the stent when the sliding part (stent sheath and cover sheath) is retracted into the intermediate shaft (non-moving part).In this case, from the situation of the occurrence, it was inferred that the distal end of the sliding part was caught on some hard object such as a stenotic lesion when the actual sample was crossing over the iliac artery from contralateral approach.It was inferred that push-in force was applied to the actual sample in that state, causing the non-moving part (inner shaft) to move forward.Due to this, the stent was pushed out and exposed partially.To confirm the above, a simulation test was conducted using a current misago sample as follows.The inner diameter of the transparent tube was narrowed with cable ties to trap the distal end of the sliding part, and then push-in force was applied to the misago sample.As a result, the stent was exposed partially from the sliding part.In the above simulation test, it was observed that the sliding part was slightly retracted into the intermediate shaft (non-moving part), and the position of the distal end of the sliding part was shifted to the proximal side.In this case, the following possibility was considered as a mechanism of occurrence based on the situation of occurrence, however, since the actual sample was not returned, it was not possible to clarify the cause of occurrence.The distal end of sliding part was caught on some hard object such as a stenotic lesion when the actual sample was crossing over the iliac artery from contralateral approach.When push-in force was applied to the actual sample in that state, the stent was exposed partially from the distal end of sliding part.In the above situation, the sliding part was slightly retracted into the intermediate shaft (non-moving part), and the position of the distal end of the sliding part shifted toward the proximal side.In addition, the distal end of sliding part deformed in flare shape.Relevant instructions for use (ifu) reference: "preparation of the stent system 2-5 if you see a gap between the sliding part and the distal tip, move the sliding part to eliminate the gap precaution"."stop using the stent system immediately if the gap cannot be eliminated by moving the sliding part.(this could cause adverse events, such as vessel damage.) do not advance the stent system by force if you feel any resistance during insertion.".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 a contralateral crossover approach to the right superficial femoral artery (sfa) from left femoral was performed.After dilatation with a balloon, the doctor tried to place the stent, however, the stent did not cross over the iliac easily despite several attempts, the stent was once removed from the patient.The distal end of the sliding part had been flared and the stent was exposed partially.The case was completed successfully with another misago of a different size with no problem.There was no patient injury/medical or surgical intervention required.The procedure outcome was completed successfully.The final patient impact was not harmed.No residues were in the patient's body.

• 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: 17049222
• MDR Text Key: 316402467
• Report Number: 9681834-2023-00102
• 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: 06/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SX-FMA07X5RN
• Device Lot Number: 211001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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