MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER® DUCT OCCLUDER II; OCCLUDER, PATENT DUCTUS, ARTERIOSUS

Device Problem Obstruction of Flow (2423)

Patient Problem Stenosis (2263)

Event Type  Injury  

Manufacturer Narrative

Product #1 pi main [(b)(4)].An event of progressive left pulmonary artery stenosis due to protrusion of a disc at the pulmonary end of the device was reported.The results of the investigation are inconclusive since the device remains implanted and was not accessible for analysis.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

It was reported through a research article identifying amplatzer ductal occluder ii (ado ii) that may be related to a stenosis.Specific patient information is documented as a 6 month old, 5.5 kg female child.Details are listed in the attached article, titled "left pulmonary artery stenting for relief of left pulmonary artery stenosis following ductal closure using amplatzer duct occluder ii." on an unknown date, an amplatzer ductal occluder ii (ado ii) was implanted.During the procedure the patient developed progressive left pulmonary artery (lpa) stenosis due to protrusion of the disc at the pulmonary end of the ado ii.The patient was subjected to balloon angioplasty of the lpa stenosis with suboptimal result.Hence, the patient was subjected to stenting of the lpa using a formula stent which could be subsequently postdilated to keep up with the growth of the patient.Immediate and short-term results were excellent anatomically as well as physiologically.

• Brand Name: AMPLATZER® DUCT OCCLUDER II
• Type of Device: OCCLUDER, PATENT DUCTUS, ARTERIOSUS
• 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: 9086173
• MDR Text Key: 162951616
• Report Number: 2135147-2019-00302
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P020024
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2019
• 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: 6 YR
• Patient Weight: 6