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

Model Number N/A

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problems Pain (1994); Stenosis (2263)

Event Date 10/04/2022

Event Type  Injury  

Manufacturer Narrative

Udi: n/a as this product code is not exported to the us market.Implanted date: unknown, explanted date: device was not explanted, device manufacture date: unknown due to unknown lot number.The actual sample was discarded by the involved facility; therefore, the actual device will not be returned for evaluation.Since the involved lot was unknown, it was not possible to investigate the manufacturing history record and the shipping inspection record.Based on the description of the event stating that the product in question was implanted about 1.5 years before the date of occurrence, which was estimated to be april 2021, review of non-conformance report for three years back from april 2021 (may 2018 - april 2021) was performed.As a result, it was confirmed that no deviations or nonconformities related to this event had occurred.Based on the results of the investigation and the description of the event, it was inferred that the stent was not sufficiently expanded at the stenotic site due to some factors (e.G., the indentation left at the same site), which resulted in the fracture of the stent in the way it was crushed inward.However, since the actual sample was not returned, the cause of occurrence could not be clarified.Relevant instructions for use (ifu) reference: "pre-dilatation of the target vessel is recommended." "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." 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 Description

The user facility reported that the misago device involved was used to treat a stenosis of the left external iliac artery (eia) (near cia).A metacross 6.0/40 was used for pre-dilation.As the lesion was dilated sufficiently, though some indentation was left in the stenotic section, the actual device (misago 10/60) was implanted.An angiographic showed no severe calcification.Since the stenosis was widened to 6 mm and some indentation remained, the procedure was finished.About 18 months later, the patient came to the hospital with intermittent claudication.The patient was unable to walk 100 m.An echo confirmed the stenosis, and the patient underwent revascularization.The stent was not fully expanded at the stenosis and was fractured in a way that it was crushed inward.In the distal section of the stent, some struts were facing outward, which also showed fracture.A wire was able to capture the true lumen, a straight angiographic catheter was inserted, replaced with a 35 wire, a 7 french long sheath was passed in through the stent, and vbx8.0/59 was implanted with dilatations repeated three times.When pressurized at approximately 12 atm, vbx expanded, and the calcified area showed a cracking behavior.The procedure was completed after confirmation by intravascular ultrasound (ivus).The event occurred intra-operative.The patient was not harmed; however, additional medical intervention was required.The procedure outcome was not reported.The final patient impact was not harmed.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer (Section G): TERUMO CORPORATION, ASHITAKA; reg. no. 9681834; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• Manufacturer Contact: gina digioia ; reg. no. 2243441; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 15756396
• MDR Text Key: 303296585
• Report Number: 9681834-2022-00219
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SX-IMA1060RN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 63 YR
• Patient Sex: Male