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 05/08/2023

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 clot on the disc was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device batch/lot number was not provided, and therefore the device history record could not be reviewed.The patient¿s medical history was not known.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 (b)(6) 2023, an unknown amplatzer amulet left atrial appendage (laa) occluder was chosen for a laa occlusion procedure.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 left to right shunt with patent foramen ovale was noted.Patient was continued on dual antiplatelet therapy (dapt) and a follow up was conducted after five months.On (b)(6) 2023, a repeat transesophageal echocardiogram (tee) was performed.On an unknown date, a clot noted on the disc.The patient status was unknown.

• 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: 18454757
• MDR Text Key: 332258999
• Report Number: 2135147-2024-00094
• 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: 02/21/2024
• 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: 02/20/2024
• 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: 69 YR
• Patient Sex: Female