MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER DUCT OCCLUDER; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Catalog Number	9-PDA-006
Medical Device Problem Codes	Migration or Expulsion of Device (1395); Off-Label Use (1494); Device Damaged by Another Device (2915); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Hemolysis (1886)
Date of Event	01/09/2025
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 a 10-8mm amplatzer duct occluder was selected for implant on (b)(6) 2024 using a 6f amplatzer torqvue delivery system to close a ruptured sinus of valsalva (sov).The defect was measured at 6mm under transesophageal echocardiogram (tee) and 4.8mm under angiography.A stability check was performed.The occluder was implanted.Approximately two weeks after the procedure the patient presented with hemolysis.On (b)(6) 2025 a cardiac catheterization showed one radiopaque marker in the aortic sinus and another radiopaque marker in the right pulmonary artery and a recurrent shunt flowed across the ruptured sov.The leak was measured greater than 5mm.The occluder was surgically removed and the ruptured sov was surgically closed.The radiopaque marker was not removed from the patient as it was not causing an obstruction.It was noted that the inferior vena cava (ivc) was protruding into the right atrium and the decision was made to trim the end of the stent.It was believed that the edge of the open stent interacted with the occluder, the open edge of the stent cutting into the nitinol wire braid of the occluder and causing the device to break into two pieces.The patient status was stable.
Additional Manufacturer Narrative
An event of migration or expulsion of device and hemolysis was reported.A returned device assessment could not be performed as the device was not returned for analysis.Reportedly, the inferior vena cava (ivc) was protruding into the right atrium and the decision was made to trim the end of the stent.It was believed that the edge of the open stent interacted with the occluder, the open edge of the stent cutting into the nitinol wire braid of the occluder and causing the device to break into two pieces.Images/video were provided showing both the index procedure and the follow up.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 reported device expulsion appears to be related to previously-implanted stent frame which was present in close proximity to the ado device.The reported surgical intervention was a result of case-specific circumstances as a device was snared and removed.There is no indication of a product quality issue with regards to manufacture, design, or labeling.Please note that per the instructions for use, "the amplatzer¿ duct occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (pda).".

• Brand Name: AMPLATZER DUCT OCCLUDER
• Common Device Name: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 21294462
• Report Number: 2135147-2025-00506
• Device Sequence Number: 21131873
• Product Code: MAE
• UDI-Device Identifier: 00811806011134
• UDI-Public: (01)00811806011134(17)260531(10)8027335
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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): 03/11/2025

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: 05/31/2026
• Device Catalogue Number: 9-PDA-006
• Device Lot Number: 8027335
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 03/05/2025
• Initial Report FDA Received Date: 02/03/2025
• Supplement Report FDA Received Date: 03/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2021
• 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: 11 YR
• Patient Sex: Female
• Patient Weight: 28 KG