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

Model Number	SXR06150R
Medical Device Problem Codes	Difficult to Remove (1528); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.No anomaly was found in the manufacturing record and the shipping inspection record of the product with the product code/lot# included.No other similar report of the product with the product code/lot# involved has been reported in the past.For information regarding the importer report for this event, please refer to section h10.Terumo medical corporation (tmc) (importer) registration no.2243441 is submitting this report on behalf of ashitaka factory of terumo corporation (manufacturer) registration no.9681834.
Event or Problem Description
The user facility reported that the physician was treating an occluded superficial femoral artery (sfa) stent in the right sfa via left common femoral access.A 7fr destination sheath was used.To treat the occluded stent, the physician placed a 6mm spiderfx wire into the popliteal artery and used jetstream.After plastying the artery, it was decided to extend the existing stents into the distal sfa with a 6mm x 150cm misago stent.This was done over the spider wire due to some clot seen in the artery.The misago stent was successfully deployed and plastied with a 6mm crosstella balloon.The physician decided to use a 5fr x 100cm glidecath to try and re-capture the spider filter wire because of the debris and clot believed to be in the basket.The physician was unable to completely capture the spider wire basket within the glidecath and attempted to pull the system through the stents partially uncaptured.It is believed that the spider wire filter basket caught the misago stent struts in two different places, causing the misago stent to bunch up and fold on itself.The physician was able to pass a 0.035 navicross past both mangled parts of the misago and stent open the misago with a 6mm x 100cm viabahn stent.The physician used ivus imaging post viabahn placement and deemed that the artery looked good, and no further intervention was needed.No hematoma or perforation of the artery was believed to have occurred due to the issue.The patient remained stable throughout, and the procedure was a success.The event occurred intra-operatively.The procedure performed was a right lower extremity (rle) angiogram with intervention.The reported blood loss was none.This was a temporary issue, with no injuries to the patient.Medical or surgical intervention requires the placement of a covered stent within the misago.Additional information was received on 12 may 2025: the physician accessed the left common femoral artery (cfa) and was treating the right sfa.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to correction d9, to update section h3 and provide the completed investigation results.The actual device was not returned and is unavailable, as the initial mdr submission was inadvertently completed with incorrect information.No anomalies were found in the manufacturing record or the product inspection record for the product with the involved product code/lot number.No other similar reports were found in the past complaint files for the product with the involved product code/lot number.Based on the investigation result, as a possible cause of this case, it was likely that since a part of misago stent was not properly crimped to the vessel wall, when the basket part of spider wire was removed, the basket part of spider wire got caught on the uncrimped part of stent.Then, further removal force was applied and the stent contracted.However, since the actual device was not returned, it was not possible to clarify the cause of occurrence.For future use, the following precaution found in the instructions for use (ifu) of this product should be noted, as appropriate.[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.Ashitaka factory manufacturing process has been making efforts in maintaining the quality of the product by performing following inspections.100% image inspection of the stent is performed to confirm that there is no anomaly such as a deformation or fracture in the stent strut.100% image inspection of the stent is performed and measure stent strut width and thickness to confirm that there is no anomaly in the dimensions of stent strut.After the product assembling process, 100% visual inspection is performed to confirm that there is no anomaly such as a kink or crush in the stent sheath or cover sheath (sliding part).After the product assembling process, the force (radial force) exerted when the stent dilates is measured on sampling basis to confirm that there is no anomaly in the radial force.

• 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: 22129206
• Report Number: 9681834-2025-00094
• Device Sequence Number: 7487437
• Product Code: NIP
• UDI-Device Identifier: 04987350727749
• UDI-Public: (01)04987350727749(17)261130(10)231220
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/02/2025

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 Model Number: SXR06150R
• Device Catalogue Number: SX*FMA06X5RN
• Device Lot Number: 231220
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 05/19/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/05/2025
• Supplement Date Received by Manufacturer: 06/02/2025
• Initial Report FDA Received Date: 06/02/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/20/2023
• 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
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White