MAUDE Adverse Event Report: TERUMO CORPORATION, ASHITAKA R2P MISAGO; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	SXR07120R
Medical Device Problem Codes	Material Fragmentation (1261); Device Dislodged or Dislocated (2923); Activation Failure (3270)
Health Effect - Clinical Codes	Pain (1994); Foreign Body Embolism (4439); Reduced Blood Flow (4598)
Date of Event	05/08/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The actual device and additional information have not been received for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.No anomalies were found in the manufacturing and shipping inspection records for the product associated with the specified product code/lot number.Additionally, no similar reports regarding this product code/lot number have been recorded in the past.For information regarding the importer report for this event, please refer to section h10.(b)(4) (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 during a lower extremity angiogram with intervention via contralateral femoral access, a physician successfully deployed a 7mm x 150cm misago stent in the superficial femoral artery (sfa) using a.035 rosen wire.A second stent, a 7mm x 120cm misago, was then prepared for implantation.According to the technologist, the stent was flushed with a syringe prior to use.Upon initiating deployment by rolling the wheel on the delivery system, the proximal shaft of the misago delivery system bent or kinked at a 90-degree angle at the strain relief of the handle, which prevented full deployment of the stent.The physician attempted to retrieve the partially deployed stent, but it began to fragment within the patient.The sheath had to be removed due to the compromised stent.Wire access was maintained, and a new sheath was introduced.A fragment of the stent was located within the tissue tract at the arteriotomy site and was successfully removed before the new sheath was placed.The physician proceeded to perform angioplasty on the sfa and deployed a protege stent.However, a fragment of the misago stent remained lodged in the iliac artery.The technologist reported that the physician may have performed angioplasty on the iliac artery to secure the stent fragment and prevent distal migration.Due to unsatisfactory pedal pulses post-procedure, the physician planned to take the patient to the operating room (or).At the time the event was reported, the patient had not yet been taken to the or.The estimated blood loss during the procedure was less than 250cc.The event resulted in the removal of the compromised stent, placement of a new stent, and retention of a stent fragment in the iliac artery.The vascular surgeon intended to bring the patient to surgery the following day.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section d9 and section h3, and to provide the completed investigation results.The actual device has been returned for evaluation.The actual device upon receipt was a misago, a fractured stent, and a competitor's sheath.Visual, magnifying, and x-ray fluoroscopic inspections were conducted on the actual misago.The lock of the thumbwheel on the main body had been released.The distal end of the anti-kinking sleeve had been kinked.The stent had been fractured.The fractured stent was elongated over the entire length, and the fractured stent strut was tapered.Therefore, it was likely the stent was fractured due to some pulling force being applied.The distal tip had been abraded.The sliding part had been moved approximately 50 millimeters toward the rear end.No anomaly, such as deformation, was found in the sliding part.No anomaly, such as deformation, was found in the fixed part of the release wire.No anomaly, such as deformation, was found in the distal shaft.No anomaly, such as deformation, was found in the intermediate shaft.The release wire had been kinked at the kinked section of the distal end of the anti-kinking sleeve.Although the distal end of the anti-kinking sleeve was kinked, no anomaly was found in other sections.The handle had been approximately 45 to 50 clicks from the release of the wire wound.No anomaly was found with the release wire wound up.After disassembling the actual device, magnifying and electron microscopic inspections were conducted.The distal end of the sliding part had been abraded.Therefore, it was inferred that some hard objects came into contact with the section involved.No anomaly, such as deformation, was found in the section where the stent was mounted on the inner shaft.The outer diameter of the sliding part met the factory's specifications, and no anomaly was found.The outer diameter of the shaft (normal section) met the factory's specifications, and no anomalies were found.A historical investigation was conducted.No anomaly was found in the production record and the product inspection record for the product code and lot number involved.No other similar reports were found in the past complaint file for the product with the product code and lot number.Visual, magnifying, and x-ray fluoroscopic inspections of the competitor's sheath revealed that the shaft had been bent.The end of the sheath had been deformed.Therefore, it was inferred that some hard objects (e.G., stents) came into contact with the involved section.The misago stent had been deployed in the lumen from the end to the direction of the rear end.The product structure and mechanism of occurrence indicate that 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 proximal end.If the stent is released while the sliding part of the delivery catheter is trapped in a calcified lesion, the sliding part will be hindered from being pulled toward the proximal end, and the stent may not be deployed with a normal number of clicks.In addition, since only the release wire is wound at that time, compressive force is applied to the shaft, causing waviness.In this state, if the thumbwheel is further rotated to attempt to release the stent, the distal shaft and the intermediate shaft will be deflected.Based on the investigation result, the following mechanisms were inferred as possible causes of this case.However, it was not possible to clarify the exact cause of the occurrence.The stent was released in a state where the distal end of the sliding part of the actual device was trapped by some hard object (e.G., calcified lesion).This hindered the sliding part from moving toward the proximal side, preventing the stent from being deployed.In addition, since only the release wire was wound up at that time, compressive force was applied to the shaft, causing the distal end of the anti-kinking sleeve to kink.Subsequently, when the misago was being removed to address the partially deployed stent, the stent got caught on the distal end of the competitor's sheath that was being used in combination with the actual device.Therefore, the misago could not be removed.Furthermore, removal force was applied to the misago, which elongated the stent and caused it to fracture.Regarding the competitor's sheath, it was not possible to clarify the cause of the bend.For future use, please keep in mind the following direction for use and precaution described in the instructions for use (ifu).Directions for use 4-3: - as a guide, stent deployment commences on rolling back the thumbwheel 5-1 0 clicks for stents up to 100 mm long and 10-15 clicks for stents at least 120 mm long.Carefully roll back the thumbwheel one click at a time and adjust the position of the stent just prior to deployment if necessary (otherwise the stent can be deployed in the wrong position).- deploy the stent completely, even if the delivery catheter bends and corrugates.- 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.) precautions: - to assure optimal stent delivery, confirm that the pre-dilation is properly done before stenting patients who have highly tortuous or calcified lesions and/or vessels proximal to the lesion.The ashitaka factory manufacturing process has been making efforts to maintain the quality of the product by performing the following inspections.A 100% inspection of the stent by an imaging device is performed to confirm that the stent strut is not deformed or fractured.A 100% inspection of the stent by an imaging device is performed, and the width and thickness of the stent strut are measured to confirm that there is no anomaly in the dimensions of the stent strut.After the product assembling process, a 100% visual inspection is performed to confirm that there is no kink or crush in the stent sheath, cover sheath (sliding part), or shaft.After the product assembling process, the release resistance of the stent is measured on a 100% basis to confirm that there is no anomaly in it.

• Brand Name: R2P MISAGO
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya, shizuok 418-0 015; JA 418-0015
• Manufacturer Contact: stephanie handy ; 950 elkton blvd.; elkton, MD 21921 ; 9499890491
• MDR Report Key: 22162287
• Report Number: 9681834-2025-00086
• Device Sequence Number: 7292671
• Product Code: NIP
• UDI-Device Identifier: 04987350727763
• UDI-Public: (01)04987350727763(17)250930(10)221006
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• 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
• Report Date (Section B): 06/06/2025

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2025
• Device Model Number: SXR07120R
• Device Catalogue Number: SX*FMA07X2RN
• Device Lot Number: 221006
• 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: 05/08/2025
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/07/2025
• Supplement Report FDA Received Date: 07/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/06/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown