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

Catalog Number	9-PDA-005
Medical Device Problem Code	Difficult to Fold, Unfold or Collapse (1254)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that on (b)(6) 2025, an 8-6mm amplatzer duct occluder was chosen for implant.During procedure, it was noted the device had a cobra deformation.A decision was made to retrieve the device prior to release from the delivery cable.The complaint device was also tested outside of patient anatomy and continued to have the same cobra deformation.A new 8-6mm amplatzer duct occluder was chosen and successfully implanted.The patient status was reported stable.
Additional Manufacturer Narrative
Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
An event of device deformity was reported.One video was received from the field showed cobra deformation on distal disc while deployed through the loader.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 available information and without the device to analyze, the cause of the reported event could not be conclusively determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
It was reported that on (b)(6) 2025, an 8-6mm amplatzer duct occluder was chosen for implant with a 6f amplatzer torqvue delivery system.During procedure, it was noted the device had a cobra deformation.A decision was made to retrieve the device prior to release from the delivery cable.There was no interaction with any cardiac structures during deployment and no angulation/kink noticed with the delivery system.The complaint device was also tested outside of patient anatomy and continued to have the same cobra deformation.A new 8-6mm amplatzer duct occluder was chosen and successfully implanted.The patient status was reported stable.

• 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: 21398992
• Report Number: 2135147-2025-00797
• Device Sequence Number: 8215112
• Product Code: MAE
• UDI-Device Identifier: 00811806011127
• UDI-Public: (01)00811806011127(17)290531(10)10395115
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• PMA/510(K) Number: P020024
• 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): 03/19/2025

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDA-005
• Device Lot Number: 10395115
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/23/2025
• Supplement Date Received by Manufacturer: 03/17/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 03/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/24/2024
• 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
• Patient Age: 12 MO
• Patient Sex: Male
• Patient Weight: 7 KG