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

Model Number 9-ASD-015

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

Patient Problem Endocarditis (1834)

Event Date 04/23/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Related manufacturer reference number: 2135147-2021-00212.It was reported that in (b)(6) 2016, a 25mm amplatzer cribriform occluder( aco) and a 15mm amplatzer septal occluder (aso) were implanted due to residual shunt.On (b)(6) 2021, infective endocarditis was confirmed with bacterial mass adhered on both the aco and the aso devices.In addition, the patient is suspected of having liver abscess/renal abscess.Antibiotic therapy was administered for 6 weeks.Then, on (b)(6) 2021, explant of both the aco and aso were performed and the defect was surgically closed with a pericardial patch.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of infective endocarditis was reported.A more comprehensive 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 information received, the cause of the reported incident could not be conclusively determined.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 12032428
• MDR Text Key: 262630953
• Report Number: 2135147-2021-00213
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 08/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Model Number: 9-ASD-015
• Device Catalogue Number: 9-ASD-015
• Device Lot Number: 4668567
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 54 YR