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

Model Number	N/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier: requested, not provided.Age & date of birth: requested, not provided.Patient sex: requested, not provided.Weight: requested, not provided.Ethnicity: requested, not provided.Race: requested, not provided.Catalog number: requested, unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.Review of the manufacturing record and the shipping inspection record of the involved product code/lot# 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# combination.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 or Problem Description
The user facility reported that the misago stent was partially deployed when the physician was preparing to load onto wire for delivery.The tech properly prepared the stent and did not notice partial deployment until the physician loaded onto wire.Another stent was used.There were no adverse events.The issue with the stent was on the back table and was never even loaded onto the wire.The patient was fine and the procedure outcome was a success.Additional information was received on 26 jan 2023: the procedure was a left lower extremity angio with intervention.The patient condition was stable.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to provide the device return date in section d9, to update section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.Visual inspection of the actual sample found that the stent had exposed approx.5 mm from the distal end of the sliding part.The thumbwheel was in lock position.Magnifying inspection of the sliding part found no kink, crush or other external anomaly in the stent mounting part; however, the sliding part had retreated by approximately 2.18 mm.Magnifying inspection of the release wire fixing part found no external anomalies, such detachment of the fixed.Magnifying inspection of the shaft section found no kink, crush, or other anomalies in the appearance.X-ray fluoroscopic inspection inside the catheter found no anomaly such as a fracture of the release wire.X-ray fluoroscopic inspection inside the deployment handle found no difference in the state of thumbwheel and of the release wire in comparison with a factory-retained sample from the same product type.The actual sample was confirmed possible to be inserted over a factory-retained 0.035" guidewire.The actual sample was submerged in lukewarm water of 37°c, the thumbwheel was unlocked, and an attempt to release the stent was made.The stent was deployed normally.The pictures were taken while the actual sample was taken out from the water.Next, magnifying inspection of the exposed stent found no anomaly in the appearance such as a deformation of or breakage in the strut.Magnifying inspection of a part of inner shaft where the stent had been mounted found no anomalies in the appearance such as a kink.Magnifying inspection of the sliding part found that the distal edge had been deformed.No abnormalities such as a crush were observed in other locations.Subsequently, electron microscopic inspection of the sliding part found that the distal edge had been dented due to force from front side.From this, it was inferred that the exposed stent met the distal edge of the sliding part, which resulted in the dent.In addition, scratches and roughness were observed on the surface of other area of sliding part.Magnifying inspection of the distal tip section found no crush, flare, or other anomalies.Electron microscopic inspection of the distal tip section found scratches on the surface.From this, it was inferred that this part was caught on some hard object.An attempt to insert the actual sample into a holder tube showed it was caught due to the point where the stent was exposed, and the insertion was not possible.In this case, it was inferred that the actual sample was caught on some hard object at some point after taken out from the holder tube, and when a pulling force in the withdrawal direction was applied to the sliding part, the sliding part retreated leading to the exposure of stent.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.According to the investigation result, no anomaly was found in the manufacturing records.The damaged section of the actual sample had undergone the 100% visual inspection during manufacturing, such level of damage was probably detected in this inspection.From the fact that multiple scratches were observed on the distal tip and stent sheath, it was likely that, after the actual sample was taken out from the holder tube, the distal tip was caught on some hard object, and subsequently, the sliding part was exposed to pulling force in the withdrawal direction and retreated leading to the exposure of stent.However, it was not possible to clarify the reason why the distal tip was caught, and tensile force was applied to the sliding part.Ashitaka factory is making efforts to maintain the product quality by performing the following operations and inspections.After the stent mounting process and before the packaging process, 100% visual inspection is performed to assure that the stent inside the sliding part has no fracture or scratches.100% visual inspection is performed to check if the distal end of the sliding part is in the specified position.This assures that the position of the sliding part is not displaced.After the product assembly, 100% release resistance test is performed to confirm that there is no abnormality in the resistance at the time of release.The instructions for use (ifu) has the following information: - 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.).
Additional Manufacturer Narrative
This report is being sent as follow-up no.2 to correct section d3.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, MD 418 ; JA 418
• 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: 16409368
• Report Number: 9681834-2023-00021
• Device Sequence Number: 17662821
• Product Code: NIP
• UDI-Device Identifier: 04987350727565
• UDI-Public: 04987350727565
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: P140002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/21/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: SXR07040R
• Device Lot Number: 201118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 09/24/2024
• Initial Report FDA Received Date: 02/21/2023
• Supplement Report FDA Received Date: 03/20/2023; 09/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/18/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MISAGO STENT
• Patient Sex: Unknown