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

Catalog Number UNK AMPLATZER VASCULAR PLUG

Device Problems Difficult to Fold, Unfold or Collapse (1254); Migration or Expulsion of Device (1395); Patient Device Interaction Problem (4001)

Patient Problem Pulmonary Embolism (1498)

Event Date 01/01/2005

Event Type  Injury  

Event Description

The article, ¿a challenging interventional procedure: transcatheter closure of tubular patent ductus arteriosus in patients with pulmonary hypertension¿, was reviewed.The article presents a retrospective, single center study that evaluated the characteristics of transcatheter closure of tubular ducts with pulmonary hypertension.Devices included in this study were starway medical cardiofix duct occluder, abbott amplatzer duct occluder (ado i and ado ii), abbott amplatzer vascular plug, abbott amplatzer muscular ventricular septal defect occluder, abbott amplatzer piccolo.The article concluded tubular ducts are highly associated with pulmonary arterial hypertension, and transcatheter closure of them is still challenging despite the developing device armamentarium.Although ado i or similar devices are widely used, off-label devices are usually needed at increasing rates.The avp ii device is unsuitable for short tubular ducts but seems the best option for long ones [the primary and corresponding author is ilker kemal yucel, department of pediatric cardiology, university of health sciences dr.Siyami ersek thoracic and cardiovascular surgery training and research hospital, istanbul, turkey, ilkerkemalyucel@yahoo.Com].The time frame of the study was from 2005 to 2022.A total of 73 patients were included in this study.The average age was 1.93 years, the average weight was 8.83 kg, and the average gender was male.Comorbidities included pulmonary arterial hypertension, heart failure, and patent ductus arteriosus (pda).

Manufacturer Narrative

It was reported that 73 patients underwent transcatheter closure of tubular patent ductus arteriosus in patients with pulmonary hypertension with abbott amplatzer vascular plug between (b)(6) 2005 and (b)(6) 2022.The average age was 1.93 years, the average weight was 8.83 kg, and the average gender was male.Summarized patient outcomes/complications of amplatzer duct occluder were reported in a research article in a subject population with multiple co-morbidities, pulmonary arterial hypertension, heart failure, and patent ductus arteriosus (pda).Some of the complications reported were protrusion to the aorta, residual shunt, surgical intervention, and hospitalization.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 VASCULAR PLUG
• 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: 17546445
• MDR Text Key: 321136552
• Report Number: 2135147-2023-03552
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K031810
• 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: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2023
• 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): Required Intervention; Hospitalization