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

Catalog Number	9-PDA2-05-06
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Obstruction/Occlusion (2422); Thrombosis/Thrombus (4440)
Date of Event	09/15/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Summarized patient outcomes/complications of amplatzer duct occluder ii were reported in a research article in a subject population with coronary cameral fistula and coronary artery aneurysm.Some of the complications reported were thrombus, obstruction, myocardial infraction and surgical intervention; these complications are anticipated for the procedure and subject population.Information from field indicated that a decision was made to explant the device via transcatheter snare and thrombus was aspirated from the patient.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.Please note that per the instructions for use, "indications and usage: the amplatzer¿ duct occluder ii is a percutaneous transcatheter occlusion device intended for the non-surgical closure of patent ductus arteriosus.".
Event or Problem Description
The article, ¿intermediate and long-term follow-up of transcatheter closure of congenital coronary cameral fistulas in infants and children: experience from a single center¿, was reviewed.The article presented a case study of a 1.25-year-old, 12kg patient with a coronary cameral fistula and coronary artery aneurysm.It was reported that on an unknown date, a 5-6mm amplatzer duct occluder ii was chosen for implant to occlude a coronary cameral fistula.After release of the device, complete right coronary artery (rca) occlusion occurred and thrombus was detected within the occluded rca.Acute inferior myocardial infarction was confirmed by twelve-lead electrocardiography (ecg).A decision was made to explant the device via transcatheter snare and thrombus was aspirated from the patient.The patient was discharged on heparin for three days followed by dual anti-platelet therapy with aspirin and clopidogrel for one month.It was reported another transcatheter closure was planned at an unknown date.The article concluded that tcc of ccfs in infants and children appears to be effective and is associated with a relatively low complication rate.Large ccfs and giant coronary artery aneurysms (caas) represent a higher risk of both acute and intermediate and long-term adverse events after closure.[the primary and corresponding author was zhiwei zhang, department of pediatric cardiology, guangdong cardiovascular institute, guangdong provincial people¿s hospital (guangdong academy of medical sciences), southern medical university, guangdong provincial key laboratory of south china structural heart disease, guangzhou, 510100, china, with corresponding email: drzhangzw@sohu.Com].

• 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: 17912302
• Report Number: 2135147-2023-04447
• Device Sequence Number: 6627213
• Product Code: MAE
• UDI-Device Identifier: 00811806011240
• UDI-Public: 00811806011240
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 10/11/2023

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?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-PDA2-05-06
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/18/2023
• Initial Report FDA Received Date: 10/11/2023
• 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: Required Intervention
• Patient Age: 1 YR
• Patient Sex: Unknown
• Patient Weight: 12 KG