MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER TALISMAN PFO OCCLUDER 30-25MM

Model Number 9-PFO-3025

Device Problem Positioning Problem (3009)

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

Event Date 12/16/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in a subsequent submission.

Event Description

It was reported that on (b)(6) 2021, a 30mm-25mm amplatzer talisman patent foramen ovale (pfo) occluder (batch/lot #8108657) was chosen for implant for the closure of a pfo.During procedure, the device was deployed shallowly and came back into the right atrium.The device was retrieved and removed from the patient without incidence.Another 30mm-25mm amplatzer talisman pfo occluder (batch/lot unknown) was opened.The pfo was crossed again with the wire and the sheath.The physician noted that there was no blood back into the new sheath as the device was going up the sheath, but this device was not deployed.The patient's blood pressure was noted to be low, and intracardiac echocardiography (ice) revealed a small pericardial effusion.The case was abandoned, and the heparin was reversed.Echocardiogram was done, and a pericardial tap was performed.The patient status was reported as stable.No additional information was provided.

• Brand Name: AMPLATZER TALISMAN PFO OCCLUDER 30-25MM
• Type of Device: AMPLATZER TALISMAN PFO OCCLUDER 30-25MM
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 13239336
• MDR Text Key: 288287826
• Report Number: 2135147-2022-00018
• 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: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PFO-3025
• Device Catalogue Number: 9-PFO-3025
• Device Lot Number: 8108657
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• 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): Required Intervention