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

Model Number	DUCT OCCLUDER
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Heart Failure/Congestive Heart Failure (4446)
Date of Event	01/01/2022
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 an unknown date, that a 12-10mm amplatzer duct occluder was successfully implanted in a patient that was previously diagnosed with a patent ductus arteriosus defect and sustained atrial fibrillation.It was noted the following day after implant, that although the patient did not experience any chest symptoms, a "huge negative t-wave" was detected on an electrocardiogram.The patient was experiencing an arrhythmia, but there was no elevation of serum creatine kinase detected.It was noted that the patient's left ventricle apex had become ballooned and there was excessive contraction at the base of the left ventricle.The patient was diagnosed with tako-tsubo-like left ventricular dysfunction.The patient was administered an angiotensin-converting enzyme (ace) inhibitor.A week later, the left ventricle function improved and the negative t-wave detected on the electrocardiogram had normalized.Thereafter, the patient did not experience any symptoms of congestive heart failure for two years.The article concludes that after the closure of the patent ductus arteriosus, the preload of the left ventricle decreases.However in this case study the afterload of the left ventricle increased.Those hemodynamics changes may result in stress to the left ventricle and results in tako-tsubo like ventricular dysfunction.This is especially true in an older patient that has less of an ability to compensate for these hemodynamic changes.This will require more attentive monitoring of geriatric patient's.
Additional Manufacturer Narrative
Summarized patient outcomes/complications of amplatzer duct occluder implant were reported in a research article in a subject population with co-morbidity of atrial fibrillation.Some of the complications reported were massive negative t-wave was confirmed, arrhythmia and excessive contraction at the base of the left ventricle; these complications are anticipated for the procedure and subject population.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device or individual patient information was received for analysis.

• 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: 15618087
• Report Number: 2135147-2022-01671
• Device Sequence Number: 12756300
• Product Code: MAE
• UDI-Device Identifier: 00811806011141
• UDI-Public: 00811806011141
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020024
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2023

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 Model Number: DUCT OCCLUDER
• Device Catalogue Number: 9-PDA-007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 12/19/2022
• Initial Report FDA Received Date: 10/17/2022
• Supplement Report FDA Received Date: 01/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Hospitalization
• Patient Age: 80 YR
• Patient Sex: Female