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); Stretched (1601)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/07/2022

Event Type  Injury  

Event Description

The user facility reported that while deploying the misago stent in the mid to proximal superficial femoral artery (sfa), the stent stretched out and fractured in the middle.The stent also went back into the sheath and the doctor had to push it back out.This caused the stent to stretch out from the sfa through the common femoral.The stent did fracture in the mid-section.The patient was in stable condition.The procedure outcome was successful.There was no patient injury/medical or surgical intervention required.The event occurred intra-operative.Additional information received on (b)(6) 2022: the stent was fractured in the mid-section and remained in the patient's body.

• 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: 15191294
• MDR Text Key: 297511878
• Report Number: 2243441-2022-00023
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 04987350727749
• UDI-Public: 04987350727749
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/08/2022,08/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: SXR06150R
• Device Lot Number: 200715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/08/2022
• Distributor Facility Aware Date: 07/12/2022
• Device Age: 23 MO
• Event Location: Hospital
• Date Report to Manufacturer: 06/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DESTINATION; WIRE
• Patient Outcome(s): Other