MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number UNK AMPLATZER OCCLUDER

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Thrombosis/Thrombus (4440); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/11/2023

Event Type  Injury  

Event Description

It was reported that on an unknown date, an unknown size device was implanted in the patient using an unknown delivery system.On 45 day follow up transesophageal echocardiogram (tee) reveled a clot on the disc.

Manufacturer Narrative

D4 - the udi number is not known as the part and lot numbers were not provided investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Manufacturer Narrative

An event of leak and thrombus on the amulet device was reported.The patient's most recently recorded international normalized ratio was requested but no information was received from site.It was not known if the patient had any hematologic disorders or systemic illness that could contribute to a hypercoagulability.Imaging provided by field showed the presence of a drt at follow up imaging.The device disc was well appositioned and at the pulmonary vein ridge, however, there was a leak noted in the 135 degree view due to the device being off axis and not apposed to tissue in this view.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.D1 - brand name: removed amplatzer septal occluder.D2a - common device name: removed transcatheter septal occluder.D2b - procode: removed mlv.D4 - catalog #: removed unk amplatzer occluder.H6 health effect - clinical code: code 4582 removed.H6 health effect - impact code: code 4614 removed.

Event Description

It was reported that on a (b)(6) 2024, an unknown size amplatzer amulet was chosen for a left atrial appendage occlusion (laao) procedure using an unknown delivery system.Patient was on 20 mg xarelto prior to laao.The amulet was implanted.Patient discharged on plavix 75mg and asa 81mg.On (b)(6) 2023, 45 day follow up transesophageal echocardiogram (tee) reveled a 0.6 cm leak and a big thrombus on the amulet device.The patient started back on xarelto 20mg x 3 months.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: 18454886
• MDR Text Key: 332199966
• Report Number: 2135147-2024-00095
• Device Sequence Number: 1
• Product Code: MLV
• 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: 02/26/2024
• 2 Devices were Involved in the Event: 1 2

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 OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/12/2023
• Initial Date FDA Received: 01/05/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 02/26/2024
• 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): Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Female