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

Catalog Number SXR07150R

Device Problems Break (1069); Activation Problem (4042)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/23/2022

Event Type  Injury  

Event Description

The user facility reported that the involved misago device was used to treat a heavily diseased superficial femoral artery (sfa) from the brachial artery.The doctor had to cross through an aortic graft and a balloon expandable stent in the ostial sfa.When the doctor rolled back the wheel on the misago, the shaft of the stent started to curl up/spiral, but the stent had not started to flower.The doctor pulled the whole stent back.The tip of the stent with the distal markers stayed in the sfa, but the rest of the device was stuck in the destination 6 fr 90cm sheath.The patient was in stable condition.There was no patient injury, medical/surgical intervention required.Additional information was received on 03 mar 2022: the tip was not removed from the patient.There was no blood loss.The procedure was not completed successfully.

• 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
• MDR Report Key: 13806894
• MDR Text Key: 287692349
• Report Number: 2243441-2022-00003
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04987350727787
• UDI-Public: 04987350727787
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/17/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: SXR07150R
• Device Lot Number: 200604
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2022
• Distributor Facility Aware Date: 02/23/2022
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 02/24/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: BALLOON EXPANDABLE STENT; DESTINATION 6 FR 90CM SHEATH
• Patient Outcome(s): Other