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

Model Number	9-ASD-018
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
Event or Problem Description
It was reported that on (b)(6) 2025, an 18mm amplatzer septal occluder was selected for implant using a 9f amplatzer trevisio delivery system.The device was sized using transesophageal echocardiogram (tee) and fluoroscopy at 16.4mm and 16mm.A 24mm amplatzer sizing balloon was inflated to stop the flow.The 18mm occluder was implanted.Transthoracic echocardiogram (tte) was performed during recovery, in which the septal occluder was not visible.Plain xray was then performed, which showed the occluder in the thoracic aorta.The patient was returned to the cath lab for retrieval.Ultrasound guidance was used for left cfa access.A 12f sheath was placed and the snare was introduced into the patient.The occluder was pulled down to the tip of the sheath and successfully pulled into the sheath with some difficulty; the occluder was removed from the patient.Tee was repeated, which showed that the patient's septal defect now measured 22mm.A new 22mm amplatzer septal occluder was successfully implanted using a new 9f amplatzer trevisio delivery system after "minnesota wiggle" was performed with no movement.Post-op ct confirmed the device was implanted in good position.The patient was reported to have been discharged in stable condition.
Additional Manufacturer Narrative
An event of device migration of implant during recovery was reported.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.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 complaints reported from this lot.Based on the information received, the cause of the reported device migration could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.From cine review: img 8273 shows xray view of occluder in thoracic aorta during retrieval procedure.
Event or Problem Description
N/a.

• 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: 21635989
• Report Number: 2135147-2025-01411
• Device Sequence Number: 21175228
• Product Code: MLV
• UDI-Device Identifier: 00811806010151
• UDI-Public: (01)00811806010151(17)280731(10)9190150
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 05/28/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 9190150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/05/2025
• Supplement Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 03/18/2025
• Supplement Report FDA Received Date: 05/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/12/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female
• Patient Weight: 85 KG