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

Model Number 9-PFO-3525

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Angina (1710); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 04/15/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that on (b)(6) 2022, a 35-25mm amplatzer talisman pfo occluder was chosen for implant.Prior to implant, it was noted that the patient had a mobile septum.The sizing balloon that was used was 12-14mm in diameter.After the device was placed, the right atrial disk appeared to be touching the aorta vertically, and the disk touched the posterior wall of the right atrium.However, the disk was not pushing on the aorta or atrium and the procedure was concluded.After the procedure, the patient was on dual anti-platelet therapy (dapt) regimen for one month, then single anti-platelet therapy (sapt) was prescribed going forward.During follow-up echocardiograms performed at 1, 3, and 6 months, no device problems were observed and there was no pericardial effusion seen.On (b)(6) 2023, the patient presented to the hospital due with chest pain.It was confirmed that the patient had cardiac tamponade, and pericardial drainage was performed.On (b)(6) 2023, perforation was seen on the ceiling of the left atrium and a thoracotomy was performed.The left atrial disc margin was partially visible next to the left atrium, and it was confirmed that the disc was partially protruding into the dorsal aorta space.The disk was endothelialized on both the left and right atrial sides, and there were no infective endocarditis (ie) findings.The plug was surgically removed, a patch closure was performed, and the wound was reinforced and closed.The patient was reported as stable.

Manufacturer Narrative

An event of chest pain, cardiac tamponade and perforation on the ceiling of the left atrium was reported.It was also reported that left atrial disc was partially protruding into aorta space and disc was endothelialized on both the left and right atrial sides.A returned device assessment could not be performed as the device was not returned for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 16940239
• MDR Text Key: 315311655
• Report Number: 2135147-2023-02133
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033345
• UDI-Public: 05415067033345
• 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,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9-PFO-3525
• Device Catalogue Number: 9-PFO-3525
• Device Lot Number: 8213788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/09/2021
• 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): Hospitalization; Required Intervention
• Patient Age: 67 YR
• Patient Sex: Female