MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER DUCT OCCLUDER (UNKNOWN); TRANSCATHETER SEPTAL OCCLUDER

Device Problem Biocompatibility (2886)

Patient Problem Thrombosis (2100)

Event Date 04/28/2020

Event Type  Injury  

Manufacturer Narrative

Further information regarding this event has been requested.If returned, investigation results will be provided in a subsequent submission.

Event Description

Reference manufacturing reference number: 2135147-2020-00241.It was reported through a research article identifying amplatzer vascular plugs and duct occluders that may be related to a complications post procedure.Details are listed in the article, titled " incidence and fate of device-related left pulmonary artery stenosis and aortic coarctation in small infants undergoing transcatheter patent ductus arteriosus closure." it was reported in the article that 44 patients underwent successful tc-pda with amplatzer vascular plug ii (30), amplatzer duct occluder ii-additional sizes(10), amplatzer duct occluder i (3)and coil-filled avpi devices (1), all via an antegrade approach from february 1, 2007 to september 1, 2018.The average age of the patients were 88 days, with an average weight of 885 grams.25 of the patients were female.The patients have the following comorbidities: genetic syndrome, necrotizing enterocolitis, retinopathy of prematurity requiring intervention, adrenal insufficiency, chronic lung disease, mechanical ventilation, and cardiac medications needed.Post procedure, the patients have the following complications: 7 of the patient had femoral arterial thromboses and all were started on lovenox therapy.

Manufacturer Narrative

Correction information for d2.Additional information for g4, g7, h2, h10.

Manufacturer Narrative

Additional information for: g4, g7 h2, h3, h6, and h10.As reported in a research article, seven patients implanted with a variety of amplatzer devices had femoral arterial thromboses.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.

• Brand Name: AMPLATZER DUCT OCCLUDER (UNKNOWN)
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10094573
• MDR Text Key: 193303772
• Report Number: 2135147-2020-00240
• Device Sequence Number: 1
• Product Code: MAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 88 DA
• Patient Weight: 1