MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM; AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Fistula (1862); Hemorrhage/Bleeding (1888)

Event Date 10/27/2020

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020, a 23mm portico valve was implanted via right transfemoral side.On (b)(6) 2020, doppler was performed, which showed a little pseudoaneurysm on the left femoral artery and a hematoma from the inguinal zone to the femur of the left femoral.No active bleeding was observed and no treatment was required.On (b)(6) 2020, mitral valve insufficiency due to paravalvular leak was observed with the patient's previously implanted 25mm ats valve and the paravalvular leak was closed with a 14/5mm amplatzer vascular plug.On (b)(6) 2020, the patient showed active bleeding on the right femoral due to mitral paravalvular leak closure procedure.Echo doppler was performed, which showed av fistula on the right femoral and a compression bandage was applied.On (b)(6) 2020, the patient developed anemia and 2 units of packed red blood cells was transfused.The patient was reported to be recovering.Clinical study patient id: (b)(6).

Manufacturer Narrative

Correction: manufacturing report 2135147-2021-00036, should not have been reported as a medical device report (mdr) as there is no indication that the device was manufactured by st.Jude medical.

Manufacturer Narrative

An event of bleeding on the "right femoral", "av fistula on the right femoral", and anemia was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM
• Type of Device: AMPLATZER¿ TREVISIO¿ INTRAVASCULAR DELIVERY SYSTEM
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11297927
• MDR Text Key: 230942942
• Report Number: 2135147-2021-00036
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 78 YR
• Patient Weight: 66