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 09/06/2023

Event Type  Injury  

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.

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.

Event Description

It was reported that on (b)(6) 2023, an unknown size amplatzer amulet was chosen for a left atrial appendage occlusion (laao) procedure using an unknown delivery system.Patient was on 5mg eliquis prior to laao.The amulet was implanted.Patient discharged on plavix 75mg and asa 81mg.On (b)(6) 2023, a follow up was conducted, no leak and clot was noted.On (b)(6) 2024, a 6 month transesophageal echocardiogram (tee) reveled huge thrombus on the amulet device.Patient was taking 81mg aspirin.

Manufacturer Narrative

An event of a huge thrombus being observed on an amulet device during a 6 month transesophageal echocardiogram (tee) was reported.Information from the field indicated that patient was on 5mg eliquis prior to laao and plavix 75mg and asa 81mg post procedure.No information was received on the patient's international normalized ratio (inr) closest to the time of the reported thrombus.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.However, imaging was received from the field and reviewed.Findings suggestive of new drt at the 6 month follow up due to significant visual change between the 45 day follow up and 6 months.Based on the information received, the cause of the reported incident could not be conclusively determined.Thrombus formation is a possible outcome of the procedure per the amplatzer amulet instructions for use.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.

• 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: 18452888
• MDR Text Key: 332260601
• Report Number: 2135147-2024-00097
• 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

• Date FDA Received: 01/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• 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; Required Intervention
• Patient Age: 78 YR
• Patient Sex: Female