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

Catalog Number 9-ACP2-007-020

Device Problems Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Angina (1710); Cardiac Arrest (1762); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 12/09/2023

Event Type  Death  

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 (b)(6) 2023, an unknown size amplatzer amulet left atrial appendage occluder was successfully implanted with no reported issue.Only observation was patient coughed a few times during the procedure.Next day follow up transthoracic echocardiogram (tte) and chest x-ray showed no issues or signs of effusion, and the patient was discharged.Two days later, the patient came in for follow up and it was noticed the patient still had cough and was also wheezing a little.Follow up imaging was done again, and nothing was found of concern.All vitals were normal as well.Several days later patient called in to complain of chest pain and cough.Advised to go to emergency room (er) and he declined to go.Called in again to office and again declined to visit local emergency room.The patient coded later in the afternoon and was transferred to the hospital for evaluation.Pericardial effusion was observed, requiring pericardiocentesis.The patient was then transferred to the intensive care unit (icu).Do-not-resuscitate (dnr) was signed and 24 hours later, the patient coded again and expired.

Manufacturer Narrative

An event of chest pain, circumferential pericardial effusion leading to cardiac tamponade was reported.It was reported that the patient was then transferred to the intensive care unit and that the patient expired due to cardiac tamponade which was attributed to the procedure.Information from field indicated that amulet occluder was successfully implanted with no reported issue.A returned device assessment could not be performed as the device remained implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The procedural images from field show that although the device was implanted more than 10 mm deeper than the amulet ifu indication, it met close criteria in the provided imaging, and the distal lobe was not within 4 mm of the pa in any provided view.The final tee images showed no pericardial effusion.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.H6 medical device problem code: code 2993 removed.

Event Description

It was reported that on 29 november 2023, an 20mm amplatzer amulet left atrial appendage occluder was successfully implanted with no reported issue.Only observation was patient coughed a few times during the procedure.Next day follow up transthoracic echocardiogram (tte) and chest x-ray showed no issues or signs of effusion, and the patient was discharged.Two days later, the patient came in for follow up and it was noticed the patient still had cough and was also wheezing a little.Follow up imaging was done again, and nothing was found of concern.All vitals were normal as well.Several days later patient called in to complain of chest pain and cough.Advised to go to emergency room (er) and he declined to go.Called in again to office and again declined to visit local er.On (b)(6) 2023, the patient coded later in the afternoon and was transferred to the hospital for evaluation.Pericardial effusion was observed circumferential, leading to cardiac tamponade.This required pericardiocentesis.The pericardial effusion was suspected to be either device or procedure related.The patient was then transferred to the intensive care unit (icu).Do-not-resuscitate (dnr) was signed and 24 hours later, the patient coded again and expired.The cause of death was reported to be due to cardiac tamponade, which was attributed to the procedure.

• Brand Name: AMPLATZER AMULET
• Type of Device: CARDIAC PLUG
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela MN 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18445279
• MDR Text Key: 331913294
• Report Number: 2135147-2024-00057
• 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: 02/27/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-ACP2-007-020
• Device Lot Number: 8683056
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/04/2024
• Supplement Dates Manufacturer Received: 02/26/2024
• Supplement Dates FDA Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/27/2022
• 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): Death; Hospitalization; Required Intervention; Other
• Patient Age: 71 YR
• Patient Sex: Male