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

Model Number N/A

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/23/2024

Event Type  Injury  

Event 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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): TERUMO CORPORATION, ASHITAKA; 150 maimaigi-cho; fujinomiya city, 418 ; JA 418
• MDR Report Key: 18743154
• MDR Text Key: 335813462
• Report Number: 2243441-2024-00001
• Device Sequence Number: 1
• Product Code: NIP
• 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: 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
• Device Operator: Health Professional
• 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
• Date Report Sent to FDA: 02/20/2024
• Distributor Facility Aware Date: 01/23/2024
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/26/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 7 X 40 MISAGO; ADDITIONAL .018 PLATFORM EQUPIMENT
• Patient Outcome(s): Required Intervention