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

Model Number 9-ASD-030

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

Patient Problem Atrial Fibrillation (1729)

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 30mm amplatzer septal occluder was implanted in a patient.A few days after the procedure on an unknown date, the patient had atrial fibrillation it is unknown if it is related to the procedure.The patient was treated with anticoagulant marevan 5mg and somalgin cardio 100mg.No pacemaker was required.The patient is stable.

Manufacturer Narrative

An event of atrial fibrillation 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 defined manufacturing specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported that on (b)(6) 2023, a 30mm amplatzer septal occluder was implanted in a patient.A few days after the procedure on an unknown date, the patient had atrial fibrillation it is unknown if it is related to the procedure.The patient was treated with anticoagulant marevan 5mg and somalgin cardio 100mg.No pacemaker was required.The patient is stable.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16935855
• MDR Text Key: 315272685
• Report Number: 2135147-2023-02112
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010229
• UDI-Public: 00811806010229
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: P000039
• 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: 07/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-030
• Device Catalogue Number: 9-ASD-030
• Device Lot Number: 7459614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2020
• 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