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

Model Number 9-PFO-035

Device Problem Biocompatibility (2886)

Patient Problem Thrombus (2101)

Event Date 11/18/2020

Event Type  malfunction  

Manufacturer Narrative

An event of a thrombus like structure on the left atrial disc off the occluder was reported.A more comprehensive assessment could not be performed as the device remains implanted 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.

Event Description

On (b)(6) 2020, a 25mm amplatzer pfo occluder was deployed, but found to be too small for the defect/tunnel.The 25mm amplatzer pfo occluder was exchanged for a 35mm amplatzer pfo occluder, which was successfully implanted.Upon detaching the 35mm amplatzer pfo occluder a thrombus-like structure was seen on trans-oesophageal echocardiogram (toe) on the left atrial disc.An additional dose of heparin was given to the patient.The patient is currently stable.

• Brand Name: AMPLATZER PFO OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11000127
• MDR Text Key: 221291822
• Report Number: 2135147-2020-00539
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806011301
• UDI-Public: 00811806011301
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: 9-PFO-035
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 6567838
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/18/2020
• Initial Date FDA Received: 12/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1