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

Model Number 9-PLUG-006

Device Problem Human-Device Interface Problem (2949)

Patient Problems Myocardial Infarction (1969); Occlusion (1984)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient underwent a transcatheter closure of a coronary-cameral fistula using two amplatzer vascular plugs sometime between june 2002 and december 2017.Six months post procedure an event of middle right coronary artery chronic total occlusion and inferior wall myocardial infarction was reported.A more comprehensive assessment could not be performed as the event was non-contemporaneously reported through a literature review and no device was received for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The article, " transcatheter closure of large coronary-cameral fistulas using the patent ductus arteriosus occluder or amplatzer vascular plugs" was reviewed this research article reported a (b)(6) year old male with a large congenital coronary-cameral fistula(ccf) who underwent successful transcatheter closure(tcc) using a 6mm and 8mm amplatzer vascular plug(avp) sometime between june 2002 to december 2017.A multidetector computed tomography was performed 6 months post-procedure and showed middle right coronary artery(rca) chronic total occlusion and the ecg showed old inferior wall myocardial infraction.The patient was asymptomatic and treated with aspirin indefinitely.The article concluded that tcc of large sized ccf's using the patent ductus arteriosus occluder or avp is a safe and effective therapy in anatomically suitable candidates, with favorable long-term outcomes.The primary author of the article is liang tang, md, department of cardiology, the second xiangya hospital of central south university, changsha, china.

• Brand Name: AMPLATZER VASCULAR PLUG
• Type of Device: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: pamela yip ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 11098908
• MDR Text Key: 225816372
• Report Number: 2135147-2020-00560
• Device Sequence Number: 1
• Product Code: KRD
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031810
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-PLUG-006
• Device Catalogue Number: 9-PLUG-006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/07/2020
• 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
• Patient Age: 3 YR