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

Device Problems Biocompatibility (2886); Positioning Problem (3009)

Patient Problems Congestive Heart Failure (1783); High Blood Pressure/ Hypertension (1908); Obstruction/Occlusion (2422)

Event Type  Injury  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported through a research article identifying amplatzer devices that may be related to complications post procedure.Details are listed in the article, titled "patients: initial and one-year follow-up results¿do we have the proper device?" it was reported in the article that 33 patients had a patent ductus arteriosus (pda) closed between 2002 and 2018.17 patients had an duct occluder type i implanted.These devices used included 8 amplatzer devices, 5 heart r, 3 cardi-o-fix, and 1 hyperion.The average age of the patients were 55 years old and has a history of pulmonary hypertension, arterial hypertension, duct calcification, atrial fibrillation, mitral regurgitation, and renal failure.The patients experienced the following complications: nitroglycerine infusion (2), groin haematoma (4), and unsatisfactory device positioning (1).It was not indicated if these complications were associated to an amplatzer device implanted or whether an ampalzter delivery system was used.

Manufacturer Narrative

As reported in a research article, out of 33 patients who had surgery to correct their patient ductus arteriosus, two patients implanted with an amplatzer duct occluder needed a nitroglycerine infusion and one duct occluder had an unstable position.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
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): AGA MEDICAL CORPORATION; 5050 nathan lane north; plymouth MN 55442
• MDR Report Key: 10145611
• MDR Text Key: 196090747
• Report Number: 2135147-2020-00265
• 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: foreign,health professional,l
• 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: 06/11/2020
• 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): Required Intervention
• Patient Age: 55 YR