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

Lot Number 7081510

Device Problem Biocompatibility (2886)

Patient Problems Skin Erosion (2075); Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.Investigation results will be provided in a subsequent submission.

Event Description

On (b)(6) 2020 the patient underwent an implant of a 35 mm amplatzer pfo occluder.3 months post procedure, the patient developed a pericardial effusion and was admitted to the hospital.The patient underwent a pericardiocentesis for treatment.The patient has been referred to cardiac surgery to remove the device today, (b)(6) 2020.A tee revealed suspected aortic erosion from the right disc of the device.The physicians suspects the device may have been too large for the patient.The patient is stable.

Manufacturer Narrative

Additional information g4, h2, h3, h6, h10.An event of erosion if the device 3 months after implant, causing a pericardial effusion was reported.A more comprehensive assessment could not be performed as the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.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): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 9981609
• MDR Text Key: 188902453
• Report Number: 2135147-2020-00164
• 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,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/15/2020

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 Lot Number: 7081510
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 05/28/2020
• Supplement Dates FDA Received: 06/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention