MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER VASCULAR PLUG II; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Catalog Number UNK AMPLATZER VASCULAR PLUG II

Device Problems Off-Label Use (1494); Patient Device Interaction Problem (4001)

Patient Problem Myocardial Infarction (1969)

Event Date 01/01/2005

Event Type  Injury  

Event 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 retrospective single center study on their experience with transcatheter closure (tcc) of coronary cameral fistulas (ccfs) in a large cohort of pediatric patients, focusing on technical aspects of the closure procedure and intermediate and long-term follow-up.Devices included in this study were coils (cook medical, bloomington, in, usa), amplatzer duct occluder ii (ado ii; abbott vascular, saint paul, minnesota, usa), amplatzer vascular plug/plug ii (avp/avp ii; abbott vascular), domestic vascular plug (starway medical technology, beijing, china), ventricular septal defect occluder (vsd occluder, lifetech scientific, shenzhen, china), atrial septal defect occluder (asd occluder, lifetech scientific), and patent ductus arteriosus occluder (pda occluder, lifetech scientific).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] the time frame of the study was from january 2005 to december 2019.A total of 81 patients were included in this study with 66 patients who underwent transcatheter closure (tcc).Of those who underwent tcc, 26 (39.4%) received an abbott device.The average age at time of procedure was 3.93 years, average weight was 15 kg, and the average gender was male.Comorbidities included congenital heart disease, recurrent respiratory infection, exertional dyspnea, chest pain, palpitation, murmur, congestive heart failure, growth retardation, non-specific ecg abnormalities, chamber enlargement, left ventricle or right ventricle dilation, coronary cameral fistula, coronary artery aneurysm.

Manufacturer Narrative

Literature article: intermediate and long-term follow-up of transcatheter closure of congenital coronary cameral fistulas in infants and children: experience from a single center.Summarized patient outcomes/complications of amplatzer vascular plug were reported in a research article in a subject population with multiple co-morbidities including coronary artery aneurysms (caas),transcatheter closure (tcc) of coronary cameral fistulas (ccfs), congenital heart disease, murmur, and congestive heart failure.Some of the complications reported were acute inferior myocardial infarction, large residual shunt, chest pain, dyspnea, and thrombus; 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.Based on the available information, the root cause of the reported event could not be conclusively determined.Please note, per amplatzer vascular plug and vascular plug ii, instructions for use, "the amplatzer¿ vascular plug and amplatzer¿ vascular plug ii are indicated for arterial and venous embolizations in the peripheral vasculature.Warnings: the safety and effectiveness of this device for cardiac uses (for example, patent ductus arteriosus or paravalvular leak closures) and neurological uses have not been established." this is considered as an off-label use of the device.However, the off-label use of the device did not contributed to the reported incident.Therefore, a letter will not be provided to address the deviation from the ifu.

• Brand Name: AMPLATZER VASCULAR PLUG II
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• 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: 17908876
• MDR Text Key: 325340492
• Report Number: 2135147-2023-04444
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K071699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK AMPLATZER VASCULAR PLUG II
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other