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

Catalog Number 9-PFO-3025

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

Patient Problem Pericardial Effusion (3271)

Event Date 11/28/2023

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) 2023, a 30-25mmamplatzer talisman pfo occluder was chosen for a patent foramen ovale (pfo) closure using a 9f amplatzer talisman delivery system.During procedure, heparin was administered and the wire across the pfo was difficult and multiple attempts were made with non abbott wires and a non-abbott sheath.The difficulty was due to anatomy of the patient.The sheath was appeared to be in good location but the device did not sit properly due to patient anatomy.The device was not device released from the delivery system and another attempt was made to cross septum.After crossing, an angiogram was performed and a contrast was noted around the heart.A pericardial effusion was noted and monitored no intervention performed.The procedure was aborted.The patient was reported stable.

Manufacturer Narrative

An event of pericardial effusion was reported.There was difficulty crossing the septum or positioning the device due patients anatomy.A returned device assessment could not be performed as the device 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 the received information the cause of reported incident could not be conclusively determined.

• 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: 18378231
• MDR Text Key: 331181540
• Report Number: 2135147-2023-05611
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 05415067033321
• UDI-Public: 05415067033321
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• 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: 01/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 9-PFO-3025
• Device Lot Number: 8670485
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• 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
• Patient Age: 58 YR