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

Device Problems Patient-Device Incompatibility (2682); Biocompatibility (2886)

Patient Problems Chest Pain (1776); Dyspnea (1816); Fatigue (1849); Headache (1880); Hypersensitivity/Allergic reaction (1907); Rash (2033); Palpitations (2467)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, asd occluders were explanted due to the patient's nickel allergy.The instructions for use, 600035-021 version 1, warns that an allergic reaction to the device may occur if the patient is allergic to nickel.The results of the investigation are inconclusive since the device was not returned 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 amplatzers that may be related to surgical explants.Specific patient information is documented as unknown.Details are listed in the attached article, titled surgical explant of asd occluder for nickel allergy symptoms, patient reported outcomes.It was reported in a study that 55 atrial septal closure devices were explanted due to nickel allergy.Of the 55 devices, 31 of the devices were amplatzer and 24 of the devices were gore helix.The symptoms that were experienced by most patients include chest pain, headaches/migraines, skin rash, palpitations, breathlessness on exertion, and fatigue.The onset of symptoms were one day to nine months post implant.Four of the 55 patients had complications post implant.Two patients had supraventricular arrhythmias and two patients had refractory serous pericarditis requiring pericardiectomy.Post explant procedure, all patients reported enhanced satisfaction and improvement in symptoms.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• 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: 9345079
• MDR Text Key: 169321356
• Report Number: 2135147-2019-00391
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/11/2019
• Initial Date FDA Received: 11/19/2019
• 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): Hospitalization; Other; Required Intervention