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

Catalog Number	9-ASD-019
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
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 a 19mm amplatzer septal occluder was selected for implant on (b)(6) 2024 using an 8f amplatzer trevisio intravascular delivery system.During the procedure, after deploying the left atrial disc and pulling it towards the septum, the occluder was observed to have pre-maturely disconnected from the delivery cable while attempting to retract the occluder back to the right atrium.On transesophageal echocardiogram (tee) a compression of the aortic root was seen.The delivery system was replaced with a new 12f non-abbott guiding sheath.The occluder was snared and removed from the patient.The same occluder was attempted to be connected to the 12f sheath, but it disconnected while attempting to pull it into the short sheath.The occluder was replaced with a new 20mm amplatzer septal occluder, which was successfully implanted.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.The patient did not present with any clinical signs or symptoms.The patient status was stable.
Additional Manufacturer Narrative
H6 health effect - remove clinical code 4582 no clinical signs, symptoms or conditions.An event of migration or expulsion of device (device migration) was reported.The device was returned to abbott for investigation and the investigation confirmed the device met functional specifications when analyzed at abbott.The device was inspected and no anomalies were found.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the information received, the reported device migration appears to be related to procedural conditions.The patient effects of obstruction/occlusion (compression of the aortic root) appears to be due to the device migration.The reported unexpected medical intervention was a result of case-specific circumstances.There is no indication of a product quality issue with regards 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: 21069273
• Report Number: 2135147-2025-00062
• Device Sequence Number: 18245055
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: (01)00811806010168(17)250228(10)7454130
• Combination Product (Y/N): N
• Initial Reporter Country: LH
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 03/04/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2025
• Device Catalogue Number: 9-ASD-019
• Device Lot Number: 7454130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2024
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 01/03/2025
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2020
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown