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

Model Number 9-ACP2-010-025

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Pericardial Effusion (3271)

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

On an unknown date, a amplatzer occluder (model unknown) was implanted.Following implant, the patient experienced a chronic pericardial effusion.The physician suspects the device may have been oversized.

Manufacturer Narrative

This device is not fda approved.

Event Description

On an unknown date, a 22mm amplatzer amulet (lot number: 6494125) was implanted.Following implant, an echo revealed that the device was not fully compressed and the physician elected to exchange the device for a 25mm amplatzer amulet.The device did not appear to be fully compressed; however, a successful tug test was performed and the physician elected to release device.1 month following implant, the patient experienced a chronic pericardial effusion due to the device.The patient is reported to be stable.The physician suspects the device may have been oversized.

Manufacturer Narrative

An event of chronic pericardial effusion was reported.The results of the investigation are inconclusive since 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 at the time of commercialization.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

On an unknown date, a 22mm amplatzer amulet (lot number: 6494125) was implanted.Following implant, an echo revealed that the device was not fully compressed and the physician elected to exchange the device for a 25mm amplatzer amulet.The device did not appear to be fully compressed; however, a successful tug test was performed and the physician elected to release device.1 month following implant, the patient experienced a chronic pericardial effusion due to the device.The effusion was treated with medication and the patient is reported to be stable.The physician suspects the device may have been oversized.

• Brand Name: AMPLATZER AMULET
• 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: 8967361
• MDR Text Key: 156796784
• Report Number: 2135147-2019-00284
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2019

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 Expiration Date: 07/31/2023
• Device Model Number: 9-ACP2-010-025
• Device Catalogue Number: 9-ACP2-010-025
• Device Lot Number: 6617071
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/09/2019
• Initial Date FDA Received: 09/05/2019
• Supplement Dates Manufacturer Received: 09/09/2019; 10/30/2019
• Supplement Dates FDA Received: 10/04/2019; 11/25/2019
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention