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	01/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that the 7 x 150 misago was deployed in a proximal superficial femoral artery (sfa) without difficulty.The medical doctor (md) then tried to pass an 8 x 80 balloon over the gwa.035 and the proximal edge of the misago would not allow the balloon to cross.The md tried smaller balloons on the.035 platform, and none would pass the proximal portion of the stent.Eventually the md changed out the.035 system for an.018 platform and was able to get a.018 balloon across the proximal portion of the stent and inflate and expand the stent and allowed him to complete the case.The md had to use additional.018 platform equipment and an additional 7 x 40 misago to deploy inside of the proximal portion of the 7 x 150 misago to ensure that it would stay open.The estimated blood loss was less than 250cc's.The reported event did result in patient injury/medical or surgical intervention.The patient's medical history was peripheral artery disease (pvd), coronary artery disease (cad).There is 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 25 jan 2024: the patient was stable the entire procedure.The procedure performed was left leg angiogram, with aspiration of thrombus, drug coated balloon, then stenting.The issue caused by the stent did delay the procedure and also required the patient to receive additional medication for the increased length of the procedure.The patient's anatomy did not seem to be the case.Up until we put the stent in, we were able to put multiple devices through that area without difficulty.

• 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: 18743154
• Report Number: 2243441-2024-00001
• Device Sequence Number: 20640382
• Product Code: NIP
• UDI-Device Identifier: 04987350727787
• UDI-Public: 04987350727787
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2024
• Report Date (Section F): 02/20/2024

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: 01/31/2026
• Device Model Number: N/A
• Device Catalogue Number: SXR07150R
• Device Lot Number: 230208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 01/23/2024
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/20/2024
• 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: 7 X 40 MISAGO; ADDITIONAL .018 PLATFORM EQUPIMENT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown
• Date Report Sent to FDA: 02/20/2024