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

Catalog Number	9-PDA2-06-06
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	11/27/2024
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) 2024, a 6mm amplatzer duct occluder was selected for implant.During procedure, the occluder "could not hold the heart tissue in place, resulting in a small amount of accumulation." the user further described that the procedure failed due to the patient's heart tissue problems, which resulted in the occluder not being able to hold the heart tissue.Therefore, the procedure was stopped and no device was ultimately implanted due to patient anatomy.There are no allegations of malfunction with the 6mm duct occluder and no allegations to the sizing of the occluder.Of note, it was reported that the patient experienced pericardial effusion.The patient was reported to have been discharged home in stable condition.No additional information was provided.
Additional Manufacturer Narrative
An event of use of device problem (could not hold the heart tissue in place) could not be confirmed.The device was returned to abbott for investigation and the device met functional specifications when analyzed under non-physiological conditions.The returned device was inspected and no anomalies were noted.Additionally, a review of the complaint history identified no similar incidents reported from this lot.Based on the available information, the reported event appears to be related to patient anatomy.The patient effects of pericardial effusion could not be conclusively determined.The reported minor injury/ illness / impairment was a result of case-specific circumstances.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: 20908319
• Report Number: 2135147-2024-06298
• Device Sequence Number: 7707211
• Product Code: MAE
• UDI-Device Identifier: 00811806011264
• UDI-Public: (01)00811806011264(17)280531(10)9095332
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/04/2025

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 Catalogue Number: 9-PDA2-06-06
• Device Lot Number: 9095332
• 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: 12/02/2024
• Supplement Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 12/11/2024
• Supplement Report FDA Received Date: 02/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown