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

Model Number 9-ASD-020

Device Problem Biocompatibility (2886)

Patient Problem Erosion (1750)

Event Date 04/08/2021

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6) 2021 a 20 mm amplatzer septal occluder was chosen for procedure.Although the patient anatomy was complex, including a dilated aorta, the device was placed successfully.One week post procedure, the patient complained of chest pain.A transthoracic echocardiogram (tte) was performed which did not reveal any abnormalities.Several days later, the patient continued to complain of chest pain.A repeat tte was performed which revealed an erosion.The patient was brought for surgical explant of the device and surgical repair of atrial septal defect.The procedure was successful and the patient has discharged and is reported to be doing well.No additional information has been provided.

Manufacturer Narrative

An event of chest pain, erosion, and device explant 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: 11932529
• MDR Text Key: 254240214
• Report Number: 2135147-2021-00205
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: 00811806010175
• 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: 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-020
• Device Catalogue Number: 9-ASD-020
• Device Lot Number: 7298905
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention