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

Model Number	N/A
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the physician was in a radial to peripheral case in which he was going to place a 6 x 40 misago in the superficial femoral artery (sfa).He was having trouble introducing the stent catheter into the sheath.When he looked, the stent had unsheathed in the hub of the destination slender.The physician had to remove the hub of the sheath in order to remove the stent.The tech made sure the release wheel had not been pushed down.He pushed it and it clicked, indicating that it had not been engaged while upon entering the sheath.The patient (pt) did not receive a stent on this day.The estimated blood loss was less than 250cc.The reported event did not result in patient injury and/or require medical or surgical intervention.There was not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.Additional information was received on 02apr2024: the patient was stable.Additional information was received on 25apr2024: while introducing the stent into the destination, it would not introduce and when the physician looked down, the stent had come off of the stent sheath.It was halfway in the hub, so he had to take off the hub of the sheath to get the stent out.He then just replaced the hub back on the sheath and continued working.

• Brand Name: R2P MISAGO RX SELF-EXPANDING PERIPHERAL STENT
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 19368392
• Report Number: 2243441-2024-00016
• Device Sequence Number: 7509613
• Product Code: NIP
• UDI-Device Identifier: 04987350727480
• UDI-Public: 04987350727480
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/22/2024
• Report Date (Section F): 05/22/2024

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: 04/30/2026
• Device Model Number: N/A
• Device Catalogue Number: SXR06040R
• Device Lot Number: 230531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 04/23/2024
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/02/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/22/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: .035 AMPLATZ GUIDEWIRE; 6FR DESTINATION SLENDER 119CM SHEATH
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic
• Patient Race: White
• Date Report Sent to FDA: 05/22/2024