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

Model Number	9-ASD-006
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Anemia (1706); Low Blood Pressure/ Hypotension (1914)
Date of Event	03/18/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device was not returned for analysis.An event of migration or expulsion of device (device embolization) was reported.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed, and the product met all specifications.Based on the information received, the cause of the reported device embolization was due to a combination of patient conditions and procedure conditions.The reported anemia and hypotension appeared to be due to procedural circumstances.The reported hospitalization and unexpected medical interventions were a result of case-specific circumstances.There is no indication of a product quality issue with regards to manufacture, design, or labeling.
Additional Manufacturer Narrative
The device is not returning for evaluation.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported on 18 march 2025 a 6mm amplatzer septal occluder was selected for implant to treat an iatrogenic atrial septal defect (iasd).The patient had an anomalous left upper pulmonary vein that drained into the right atrium and a large left atrial appendage (laa).Numerous attempts were made to pass a stiff wire into the left upper vein but were unsuccessful.The wire continued to go into the right lower pulmonary vein, however the patient experienced a brief drop in blood pressure and a short duration of bradycardia when the wire was left in for too long.A 3-dimensional image of the defect was captured, measuring the defect at 4.5-5mm.During the procedure the occluder was partially re-captured once.Transthoracic echocardiogram (tte) confirmed good device placement with rim capture and a push and pull test was successfully performed.Upon release from the delivery cable, the occluder embolized to the left ventricle.An attempt was made to snare the device with a goose neck snare, however the occluder was pushed into the descending aorta.The physician went retrograde through the left femoral artery to snare the occluder.There was difficulty snaring the pin on the occluder but the occluder was eventually successfully snared and removed from the patient.The patient's blood pressure dropped and the hemoglobin level then dropped from 13 to 5, requiring a blood transfusion.Epinephrine was administered for blood pressure support.The patient was assessed for an aortic dissection but was confirmed that none was present.After the blood transfusion the patient's hemoglobin level returned to normal.The patient was admitted to the pediatric intensive care unit (picu) for overnight observation.The user believed the occluder embolization was due to a combination of the patient's pre-existing epstein barr, the draining of the anomalous left upper pulmonary vein into the right atrium, along with the high jet of regurgitation.The patient was 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: 21816395
• Report Number: 2135147-2025-01874
• Device Sequence Number: 7329052
• Product Code: MLV
• UDI-Device Identifier: 00811806010038
• UDI-Public: (01)00811806010038(17)260731(10)8118162
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/31/2026
• Device Model Number: 9-ASD-006
• Device Catalogue Number: 9-ASD-006
• Device Lot Number: 8118162
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/18/2025
• Supplement Date Received by Manufacturer: 04/30/2025
• Initial Report FDA Received Date: 04/10/2025
• Supplement Report FDA Received Date: 05/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/31/2021
• 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: 24 MO
• Patient Sex: Female
• Patient Weight: 11 KG