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

Catalog Number	9-ASD-034
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that on (b)(6) 2024, a 34mm amplatzer septal occluder was chosen for implant using a 12f amplatzer trevisio intravascular delivery system.During device preparation, the physician noticed that a part was missing at the tip of the loader.During procedure, when the device was partially deployed (left disc exposed) and fully retracted into the delivery system, a thread was showing between the tip of the delivery sheath and the left disk during deployment.They stopped manipulating/deploying the device when the thread was noted.After recapturing the device, a transesophageal echocardiogram (tee) was taken and noticed a 7.5mm x 4mm thrombus was noted in the left atrial appendage (laa).The shape of the thrombus was circular and the act were between 220s and 240s throughout the procedure.At end of the procedure the act was measured again and it was 238, total of 5500 units of heparin was given during the procedure.The physician mentioned the sheath was in the patient for a significant period of time.The patient will remain hospitalized for two days under observation and will take anticoagulants for the next 6 months.The patient remained hemodynamically stable throughout the procedure.There was some delay in the procedure due to the complex anatomy and the few deployment attempts.The patient has been discharged and recovering.
Additional Manufacturer Narrative
An event of a material protrusion was reported.A returned device inspection, to rule out any device-related issues or anomalies, 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.Received imaging shows the delivery sheath across the atrial septum (red arrow) and possible thread (yellow arrow) noted but could not be conclusively determined.Based on available information and without the device to analyze, the cause of the reported event could not be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: 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: 21120718
• Report Number: 2135147-2025-00243
• Device Sequence Number: 20698818
• Product Code: MLV
• UDI-Device Identifier: 00811806010243
• UDI-Public: (01)00811806010243(17)280331(10)9010014
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ASD-034
• Device Lot Number: 9010014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 01/09/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/24/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Sex: Female