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

Catalog Number 9-ACP2-007-022

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

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

Event Date 11/17/2023

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2023, a 22mm amplatzer amulet left atrial appendage occluder was chosen for implant, with a 12f amplatzer torqvue 45x45 delivery sheath.Pre-procedural transesophageal echocardiography (tee) noted, the patient had baseline pericardial effusion with fluid noted, around the left ventricle.During procedure, it was noted, the patient's activated clotting time (act) levels were 257 seconds and the patient was administered 7k of heparin.It was reported, the patient had a thick lipomatous septum that made the transseptal puncture difficult and required a second puncture.Device preparation was followed, per instructions for use (ifu) with no air noted.During the first deployment attempt, the location was not acceptable and the device was recaptured into the ball formation.The device was then advanced forward, but in "spearlike" position and proctoring.Physician stopped operating to readjust the device back into ball position.After device deployment, perforation was noted.And fluid was also noted, in the left atrial appendage.The operating physician proceeded with device deployment to stop the effusion in the left atrial appendage.A decision then made to perform a pericardiocentesis and 500cc of blood was drained.Reversal agent, protamine, was administered to reverse heparin.The patient's blood pressure was stabilized.And transferred to intensive care unit (icu) for recovery.The patient status was reported stable and discharged to home.

Manufacturer Narrative

An event of perforation and fluid noted in the left atrial appendage after deployment was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.It was reported the patient had a thick lipomatous septum that made the transseptal puncture difficult and required a second puncture, this difficulty may have contributed to the reported event.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.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.Please note that per the instructions for use, "if device repositioning is required: partially recapture the device by maintaining tension on the delivery cable and readvancing the delivery sheath to retrieve the disc and part of the lobe until the platinum thread marker is aligned with the distal edge of the delivery sheath¿s marker band (see figure 4).Do not retract the device any farther to prevent damaging the delivery sheath.".

• 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: 18322747
• MDR Text Key: 330428076
• Report Number: 2135147-2023-05494
• 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: 01/05/2024

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-ACP2-007-022
• Device Lot Number: 8816670
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 01/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/23/2022
• 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
• Treatment: AMPLATZER TORQVUE 45X45 DS, 9-TV45X45-12F-080
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male