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

Catalog Number	9-ASD-016
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/26/2024
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 on (b)(6) 2024, a 16mm amplatzer septal occluder was selected for implant in an asd of 6.1 mm x 7.5 mm with left to right shunt.During the procedure, the device was successfully implanted.Immediately after, it was noted that the device had embolized into the femoral aorta.The device was successfully removed from the patient via percutaneous retrieval.A 35mm amplatzer multifenestrated septal cribriform occluder was then implanted.The physician doesn't believe that the patient experienced any adverse health consequences due to the performance of the product.The physician believes the cause of the embolization was due to complex anatomy with a long, thin and aneurysmatic septum.There was an increase in procedure time, but the patient remained hemodynamically stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device (device embolization) 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 embolization was due to complex anatomy with a long, thin and aneurismatic septum and so much movement of the device.The reported hospitalization and unexpected medical intervention were resulted of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2024, a 16mm amplatzer septal occluder was selected for implant in an asd of 6.1 mm x 7.5 mm with left to right shunt.During the procedure, the device was successfully implanted.Immediately after, it was noted that the device had embolized into the femoral aorta.The device was successfully removed from the patient via percutaneous retrieval.A 35mm amplatzer multifenestrated septal cribriform occluder was then implanted.The physician doesn't believe that the patient experienced any adverse health consequences due to the performance of the product.The physician believes the cause of the embolization was due to complex anatomy with a long, thin and aneurismatic septum.There was an increase in procedure time, but the patient remained hemodynamically stable.

• 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: 20989637
• Report Number: 2135147-2024-06517
• Device Sequence Number: 8599853
• Product Code: MLV
• UDI-Device Identifier: 00811806010137
• UDI-Public: (01)00811806010137(17)260831(10)8150569
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted 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): 02/12/2025

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: 08/31/2026
• Device Catalogue Number: 9-ASD-016
• Device Lot Number: 8150569
• 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: 11/26/2024
• Supplement Date Received by Manufacturer: 02/04/2025
• Initial Report FDA Received Date: 12/20/2024
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Hospitalization
• Patient Age: 58 YR
• Patient Sex: Male
• Patient Weight: 59 KG