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

Catalog Number	9-ASD-007
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/29/2023
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) 2023, an atrial septal defect (asd) closure procedure was performed.Under transesophageal echocardiogram (tee), it was discovered that the patient had two small asds: one posterior, one anterior.The posterior defect was measured to be 13mm, using a 18mm amplatzer sizing balloon ii.The anterior defect was measured to be 5.5mm, using a 18mm amplatzer sizing balloon ii and had a 1mm aortic rim at its most anterior point and was oval-shaped, extending posterosuperiorly across the septum.A 14mm amplatzer septal occluder was implanted on the posterior defect, using an 8f amplatzer trevisio intravascular delivery system.A 07mm amplatzer septal occluder was implanted on the anterior defect, using the same 8f amplatzer trevisio intravascular delivery system.Both devices passed the push/pull test to confirm sufficient tissue capture and stability and were released, respectively.On (b)(6) 2023, it was observed that the 07mm amplatzer septal occluder had embolized and was found in the descending aorta.The patient experienced mild dissection in the left common iliac artery.The physician suspects the cause of embolization was due to aneurysmal septum.The device was able to be removed via transcatheter snare.The patient is reported to be stable and was discharged.
Additional Manufacturer Narrative
An event of device embolized into descending aorta and mild dissection in left common iliac artery 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.Based on the information received, the cause of the reported incident could not be conclusively determined.There is no indication of a product quality issue with respect to labeling design or manufacturing of the device.

• 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: 17606088
• Report Number: 2135147-2023-03696
• Device Sequence Number: 6284021
• Product Code: MLV
• UDI-Device Identifier: 00811806010045
• UDI-Public: 00811806010045
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/20/2023

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 Expiration Date: 08/31/2026
• Device Catalogue Number: 9-ASD-007
• Device Lot Number: 8160507
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/01/2023
• Supplement Date Received by Manufacturer: 08/28/2023
• Initial Report FDA Received Date: 08/23/2023
• Supplement Report FDA Received Date: 09/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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: Life Threatening; Required Intervention
• Patient Age: 14 YR
• Patient Sex: Female
• Patient Weight: 48 KG