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 06/05/2023

Event Type  malfunction  

Manufacturer Narrative

D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: vascular surgeon.Review of the manufacturing record and the shipping inspection record of 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 on the involved product code/lot# from other facilities.Since the actual sample was confirmed to be an infected product on june 8, 2023, the investigation was conducted with no actual sample as follows.1.The provided picture of the actual sample showed that the stent was deployed.2.A factory-retained 0.035" glidewire advantage was inserted into a factory-retained r2p destination slender, and then a current misago sample was inserted over the glidewire into the r2p destination slender.The current misago sample was possible to be inserted with no resistance.No displacement of the distal end of sliding part was observed after the insertion.Simulation test: 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, considering the occurrence situation of the event, it was inferred that the distal end of the sliding part of the actual sample got caught on the bypass graft in the subclavian for some reason.It was inferred that push-in force was applied to the actual sample in that condition, causing the non-moving part (inner shaft) to move forward, and due to this, the stent was pushed forward 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.Subsequently, an attempt to remove the misago was made.As a result, the exposed part of the stent was caught on the hemostasis valve of destination.When further removal was continued to take misago outside of the body under resistance, the exposed part of the stent began to deploy.From the occurrence situation, the following possibility was considered as a mechanism of occurrence; however, since the actual sample was not returned, it was not possible to clarify the cause of occurrence.1.The distal end of the sliding part of the actual sample was caught in the bypass graft in the subclavian for some reason.2.When push-in force was applied to the actual sample in the above situation, the stent was partially exposed from the distal end of the sliding part.3.In the above situation, the sliding part was in the state slightly retracted into the intermediate shaft (non-moving part) and the position of the distal end of the sliding part was shifted toward the proximal side.4.When an attempt to remove the actual sample was made, the exposed part of the stent was caught on the hemostatic valve of r2p destination slender.5.When further removal was continued to take misago outside of the body under resistance, the exposed part of the stent began to deploy.The stent came out of the distal end of the sliding part partially and deployed, leading to the status of the actual sample.Ashitaka factory is making efforts to maintain the product quality by performing following work and inspections.100% visual inspection is performed before the packaging to check if the stent is properly mounted.It is also confirmed that there is no deformation in the sliding part or the shaft section.100% visual inspection is performed to check if the distal end of the sliding part is in the specified position to confirm there is no misalignment of sliding part.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.[precautions] 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 the misago went in the destination slender during radial access.Physician stated it felt tight as it moved into subclavian bypass graft.They tried to remove the sheath and it was very difficult to do so.As they removed the misago catheter, the stent was deployed off of the catheter on it's own.The patient was stable and procedure outcome was successfully ballooned superficial femoral artery (sfa) lesion.The artery of the lower extremity had been previously treated.It was a bypass from the subclavian to the superfical femoral artery (sfa) type of treatment: bypass.Lesion treatment history: de novo.Diseased limb: left.Locations: sfa.Calcification: moderate.Tortuousness: mild.Lesion length approx.(mm): 40.% diameter stenosis: 70.Reference vessel diameter approx.(mm): 6.Site of access/puncture & approach: radial artery.Lesion treatment history pre-dilatation: yes.Post-dilatation: no.Additional information was received on 08 jun 2023: the patient was positive for esbl in his urine.

• 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: 17263539
• MDR Text Key: 318575950
• Report Number: 9681834-2023-00128
• Device Sequence Number: 1
• Product Code: NIP
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2023
• Device Model Number: N/A
• Device Catalogue Number: SXR06040R
• Device Lot Number: 201005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/05/2023
• Initial Date FDA Received: 07/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/05/2020
• 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
• Treatment: DESTINATION SLENDER SHEATH; GLIDEWIRE
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 75 KG