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

Catalog Number 9-ACP2-010-025

Device Problems Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682)

Patient Problems Perforation (2001); Tachycardia (2095); Pericardial Effusion (3271)

Event Date 12/08/2023

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 08 december 2023, a 25mm amplatzer amulet left atrial appendage occluder was chosen for implant in a chicken wing anatomy using a 14f non-abbott delivery sheath.During procedure, the patient's activated clotting time (act) levels was between 250-300s and heparin was administered.The device was completely retracted into the delivery system without changing the sheath.Due to the difficult anatomy, after few attempts to position the device, the wall was perforated and caused pericardial effusion and tachycardia.The device was removed prior to release.A pericardiocentesis was performed and patient needed a surgery.The patient was reported stable.

Manufacturer Narrative

An event of pericardial effusion, tachycardia, and perforation were reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The stabilizations wires were in place on the device and no anomalies were noted to the braiding of the cable or to the shape of the device.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There are multiple risk factors for pericardial effusion after a left atrial appendage closure procedure, including anticoagulation status of the patient, maneuvering of the guidewire or sheaths within the heart, the trans-septal puncture, or the stabilizing wires on the amulet puncturing the laa.It was reported that the device was completely retracted into the delivery system without changing the sheath.Due to the difficult anatomy, after few attempts to position the device, the wall was perforated and caused pericardial effusion and tachycardia.The device was removed prior to release.A pericardiocentesis was performed and patient needed a surgery.The patient was reported stable.Based on the available information, the cause of the reported incident appears to related to patient anatomy (due to the difficult anatomy).The reported improper or incorrect procedure or method is due to the user did not change the sheath.Please note that per the instruction for use, stated "warning: if the device is retracted farther than the radiopaque markers, do not readvance the device or perform injections.The device and the delivery sheath must both be removed and replaced.

• 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 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 18427110
• MDR Text Key: 331810577
• Report Number: 2135147-2024-00004
• Device Sequence Number: 1
• Product Code: NGV
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P200049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/08/2024

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: 9-ACP2-010-025
• Device Lot Number: 9005873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2023
• Initial Date FDA Received: 01/02/2024
• Supplement Dates Manufacturer Received: 02/06/2024
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 80 YR
• Patient Sex: Male