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 Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/22/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6)2025, a 19mm amplatzer septal occluder was chosen for a 17×14 atrial septal defect (asd) closure procedure using a 9f amplatzer trevisio intravascular delivery system.The sizing of the device was determined by transesophageal echocardiogram (tee).During procedure, the right atrial disc was dislodged into the left atrium (la) with wiggled.The patient had a very small left atrium, making the placement challenging.The device was not released form the delivery cable.The physician mentioned the cause of migration was floppy posterior and inferior rims.A new 20mm amplatzer septal occluder was successfully replaced with the same delivery system and the closure was completed.There were no bends or kinks been observed in the delivery sheath.The patient was reported discharged.
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device migration) was reported.A returned device 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.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.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: 21369193
• Report Number: 2135147-2025-00700
• Device Sequence Number: 15562149
• Product Code: MLV
• UDI-Device Identifier: 00811806010168
• UDI-Public: (01)00811806010168(17)260930(10)8190098
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 03/06/2025

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 9-ASD-019
• Device Lot Number: 8190098
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/22/2025
• Supplement Date Received by Manufacturer: 02/25/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 03/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/21/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 9F AMPLATZER TREVISIO INTRAVASCULAR DELIVERY SYSTEM.
• Patient Age: 6 YR
• Patient Sex: Female
• Patient Weight: 20 KG