MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER PFO OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Model Number 9-PFO-035

Device Problem Human-Device Interface Problem (2949)

Patient Problem Dyspnea (1816)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

In 2018, a 35mm amplatzer pfo occluder was successfully implanted in a (b)(6) year old female with a history of aortic insufficiency at (b)(6) hospital.On an unknown date, the patient presented with shortness of breath and an echo was performed.A residual shunt was noted mid septum behind the disc of the pfo device.The patient was referred to surgery for device removal and the pfo and residual shunt were closed using a surgical patch.The patient recovered and was discharged from the hospital.

Manufacturer Narrative

Additional information for:g3, g6, h2, h6, and h10.The reported event of shortness of breath and residual shunt could not be confirmed.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 PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 11325362
• MDR Text Key: 232203900
• Report Number: 2135147-2021-00053
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-035
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/15/2021
• Initial Date FDA Received: 02/12/2021
• Supplement Dates Manufacturer Received: 02/18/2021
• Supplement Dates FDA Received: 02/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR