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

Model Number 9-PFO-2518

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 05/04/2023

Event Type  Injury  

Event Description

It was reported that on an unknown date and year, a 25mm amplatzer amulet was selected for an implant.During deployment, the position was acceptable but too compressed by the device.The device was retrieved according to the ifu's and replaced with a 22mm amplatzer amulet with satisfactory result.Concomitant patent foramen ovale (pfo) closure procedure was performed with amplatzer talisman pfo occluder 25mm -18mm after the left atrial appendage occlusion (laao) closure.About 30 minutes after the case in the recovery room the patient started to feel some pain in the stomach and the blood pressure was dropping.Pericardial effusion was noted on transthoracic echocardiogram (tte) that lead to cardiac tamponade.A pericardiocentesis was then performed and the excess fluid was successfully drained.A scan was performed at the end of the day and showed no pericardial effusion.The patient is stable and recovering.

Manufacturer Narrative

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

Event Description

Updated b5 event description: it was reported that on an unknown date and year, a 25mm amplatzer amulet was selected for an implant.During deployment, the position was acceptable but too compressed by the device.The device was retrieved according to the ifu's and replaced with a 22mm amplatzer amulet with satisfactory result.Concomitant patent foramen ovale (pfo) closure procedure was performed with amplatzer talisman pfo occluder 25mm -18mm after the left atrial appendage occlusion (laao) closure.About 30 minutes after the case in the recovery room the patient started to feel some pain in the stomach and the blood pressure was dropping.Pericardial effusion was noted on transthoracic echocardiogram (tte) that lead to cardiac tamponade.A pericardiocentesis was then performed and the excess fluid was successfully drained.A scan was performed at the end of the day and showed no pericardial effusion.The patient is stable and recovering.

Manufacturer Narrative

An event of pericardial effusion and cardiac tamponade was reported.A returned device assessment could not be performed as the device remains implanted and was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met all specifications.Based on information received the cause of the reported incident could not conclusively be determined but may have been related to the manipulations and maneuvering of the device within the heart.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.B5 - updated event description added.

• 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: 17003631
• MDR Text Key: 315991961
• Report Number: 2135147-2023-02316
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033314
• UDI-Public: 05415067033314
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 05/25/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-2518
• Device Catalogue Number: 9-PFO-2518
• Device Lot Number: 8852266
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2023
• 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
• Patient Age: 68 YR
• Patient Sex: Female
• Patient Weight: 67 KG