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

Catalog Number 9-PFO-2518

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 02/27/2024

Event Type  Injury  

Manufacturer Narrative

Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

The abstract from " the 34th japanese society of congenital interventional cardiology program/abstract" p.93, jc-2 titled " the case which the amplatzer pfo occluder was required to be removed due to thrombus adhering." was reviewed.It was reported that in an unknown date, 30-25mm amplatzer talisman patent foramen ovale (pfo) occluder was chosen for implant.The patient has a history of hypermenorrhea and hypoferric anemia.Transesophageal echocardiogram (tee) was performed to investigate detail what might have caused juvenile cerebral infarction then pfo was confirmed.Paradoxical brain embolism via pfo was thought to be the cause of cerebrovascular infarction.The patient was presented to the hospital for pfo closure procedure.The procedure was performed with local anesthesia and ice guided.Interatrial septal aneurysm was observed with a tunnel length of 9mm, tunnel width of 4mm, and interatrial septal length of 39mm.Pfo was measured 7mm by the sizing balloon.As there was interatrial septal aneurysm, a 30-25mm amplatzer talisman pfo occluder was chosen for implant.During deployment, the left disc deformed into s wine-glass-like shape.The occluder was never released from the delivery cable but retracted into the delivery sheath and taken out from the patient.When the device was pulled out of the sheath, thrombus formation was confirmed inside of the sheath.The delivery sheath was carefully flushed out, and a replacement 25-18mm amplatzer talisman pfo occluder was deployed with no reported issue.Subsequent observation revealed a string-like thrombus on the left atrial disc.The device was removed via transcatheter snare.After cleaning the device, sufficiently flushing the sheath, and reconfirming that activated clotting time (act) was sufficient, the 25mm device was placed without complications and the procedure was completed.

Manufacturer Narrative

As reported in a research article, the case which the amplatzer pfo occluder was required to be removed due to thrombus adhering.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.Please note that per the instructions for use, "this device was sterilized with ethylene oxide and is for single use only; never reuse or re-sterilize the system.Use of expired, reused, or re-sterilized devices may result in infection.".

Event Description

The abstract from " the 34th japanese society of congenital interventional cardiology program/abstract" p.93, jc-2 titled " the case which the amplatzer pfo occluder was required to be removed due to thrombus adhering." was reviewed.It was reported that in an unknown date, 30-25mm amplatzer talisman patent foramen ovale (pfo) occluder was chosen for implant.The patient has a history of hypermenorrhea and hypoferric anemia.Transesophageal echocardiogram (tee) was performed to investigate detail what might have caused juvenile cerebral infarction then pfo was confirmed.Paradoxical brain embolism via pfo was thought to be the cause of cerebrovascular infarction.The patient was presented to the hospital for pfo closure procedure.The procedure was performed with local anesthesia and ice guided.Interatrial septal aneurysm was observed with a tunnel length of 9mm, tunnel width of 4mm, and interatrial septal length of 39mm.Pfo was measured 7mm by the sizing balloon.As there was interatrial septal aneurysm, a 30-25mm amplatzer talisman pfo occluder was chosen for implant.During deployment, the left disc deformed into a wine-glass-like shape.The occluder was never released from the delivery cable but retracted into the delivery sheath and taken out from the patient.When the device was pulled out of the sheath, thrombus formation was confirmed inside of the sheath.The delivery sheath was carefully flushed out, and a replacement 25-18mm amplatzer talisman pfo occluder was deployed with no reported issue.Subsequent observation revealed a string-like thrombus on the left atrial disc.The device was removed via transcatheter snare.After cleaning the device, sufficiently flushing the sheath, and reconfirming that activated clotting time (act) was sufficient, the 25mm device was placed without complications and the procedure was completed.

• Brand Name: AMPLATZER TALISMAN PFO 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: 18945458
• MDR Text Key: 338185735
• Report Number: 2135147-2024-01263
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: 05415067033314
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P120021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-PFO-2518
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• 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: 40 YR
• Patient Sex: Female