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

Model Number 9-ASD-020

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Poor Visibility (4072)

Patient Problems Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Cardiac Perforation (2513)

Event Date 03/24/2023

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 (b)(6) 2023, a patient's atrial septal defect was sized 18mm and 22mm with a 24mm amplatzer sizing balloon.It was noted the patient had a weak retroaortic rim and a "very floppy" septum.A decision was made to implant a 20mm amplatzer septal occluder.The patient was administered heparin during the procedure as the device was passing through the left atrium.It was reported that the prosthesis was not visible during the operation but it did not come in contact with the aorta.After the device was placed, it was reported the shunt was stopped and stability tests were carried out to confirm placement of the device.There was no report of any complete retractions of the device into the delivery system or any difficulties experienced implanting the device.The patient's pericardium was checked before and after the procedure with nothing to report.It was reported the procedure ended at 4 p.M.And the patient was given anticoagulant treatment at 7 p.M.It was then reported during the night, patient experienced cardiac tamponade at 5 a.M.On (b)(6) 2023.The patient was drained but it was reported the bleeding did not stop.A decision was made to perform a sternotomy and the physician discovered and treated a wound on the aorta and a small wound in the left atrium.It could not be confirmed what the cause of the aortic wound and/or the small wound in the left atrium was.The patient status was reported as stable and the patient was admitted for prolonged hospitalization due to treatment to repair the wounds.

Manufacturer Narrative

An event of cardiac tamponade was reported.A returned device assessment could not be performed as the device was not returned for analysis.Abbott requested for operative notes and/or procedure imaging but this was not provided by the site.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed and the product met specifications.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labelingh6 medical device problem code: code 2993 removed.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL #3014918977; edificio #44 calle 0, ave. 2; el coyol alajuela 1897- 4050; CS 1897-4050
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 16796528
• MDR Text Key: 313836420
• Report Number: 2135147-2023-01773
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00811806010175
• UDI-Public: 00811806010175
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2023
• 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: 8502440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/02/2022
• 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
• Treatment: AMPLATZER TREVISIO INTRAVASCULAR DS, 9-ATV09F45/80.
• Patient Outcome(s): Required Intervention