MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER AMULET; CARDIAC PLUG

Catalog Number UNK AMPLATZER AMULET

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Pericardial Effusion (3271)

Event Date 10/05/2023

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that on an (b)(6) 2023 an unknown size amplatzer amulet left atrial appendage occluder was chosen for implant using an unknown delivery system.During procedure, heparin was administered.The amulet was successfully implanted without any difficulties.Post procedure, on an unknown date, patient had a small pericardial effusion (pe).The patient did not require any type of intervention to treat the pe, and there was no delay in their discharge to home.

Manufacturer Narrative

An event of pericardial effusion was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Information obtained from the field indicated that after procedure, patient had a small pericardial effusion (pe).The patient did not require any type of intervention to treat the pe, and there was no delay in their discharge to home.Based on the available information, the root cause of the reported pericardial effusion could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER AMULET
• Type of Device: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18191835
• MDR Text Key: 328802711
• Report Number: 2135147-2023-05147
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/08/2024

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER AMULET
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/01/2023
• Initial Date FDA Received: 11/22/2023
• Supplement Dates Manufacturer Received: 01/04/2024
• Supplement Dates FDA Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other