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

Catalog Number	9-PDA2-06-04
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	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a 6mm x 4mm amplatzer duct occluder ii was selected for implant on (b)(6) 2024 using a 5f non-abbott delivery sheath.During implant, the device took on a cobra shape.The device was removed from the patient.There was some interaction between the device and cardiac structures.There were no angulation or kinks noted in the delivery system.The patient remained hemodynamically stable throughout the procedure.There were no clinically significant delays in the procedure.The procedure was postponed.There were no adverse effects to the patient.The patient status was 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 difficult to fold, unfold or collapse associated with device deformation did not be confirmed.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 defined manufacturing specifications.Reportedly, during implant, the device took on a cobra shape.The device was removed from the patient.There was some interaction between the device and cardiac structures.There were no angulation or kinks noted in the delivery system a 5f non-abbott delivery sheath was used.Based on the information reviewed and returned device analysis, the cause of the reported device deformation could not be conclusively determined.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER DUCT OCCLUDER II
• 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: 19705802
• Report Number: 2135147-2024-03283
• Device Sequence Number: 17069128
• Product Code: MAE
• UDI-Device Identifier: 00811806011257
• UDI-Public: (01)00811806011257(17)280430(10)9064918
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• 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): 08/22/2024

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-PDA2-06-04
• Device Lot Number: 9064918
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/15/2024
• Supplement Date Received by Manufacturer: 08/01/2024
• Initial Report FDA Received Date: 07/09/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: 5F COOK MULLINS SHEATH
• Patient Sex: Unknown