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

Catalog Number UNK AMPLATZER PFO OCCLUDER

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Arrhythmia (1721); Non specific EKG/ECG Changes (1817); Fatigue (1849); Obstruction/Occlusion (2422)

Event Date 10/13/2023

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 an unknown date, an amplatzer patent foramen ovale (pfo) occluder was implanted.A few days after implant, patient presented with symptoms of weakness, palpitations, and extrasystoles.On (b)(6) 2023, a coronary angiography was performed, and a congenital malformation (left coronary origin from right coronary) was noticed with a left coronary compression from the device.On (b)(6) 2023, the device was explanted by open heart surgery.The patient was reported stable after the explant procedure.

Manufacturer Narrative

An event of the patient having weakness, palpitations and extrasystole symptoms was reported.Information from the field indicated that the patient had a congenital malformation with the left coronary origin from right coronary.Imaging was received from the field which was examined by abbott medical affairs.The review found that the still angiogram showed partial compression of the left coronary artery originating from the right coronary artery by the inferior edge of the right atrial disc of the amplatzer pfo device.There was blood flow through the compression site, but this could be impacted by physical activity.The compression of the artery could cause the symptoms reported.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER 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: 18092055
• MDR Text Key: 327623498
• Report Number: 2135147-2023-04910
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 01/02/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER PFO OCCLUDER
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2023
• 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): Required Intervention