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

Model Number 9-ASD-MF-025

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

Patient Problems Chest Pain (1776); Dyspnea (1816); Headache (1880); Hypersensitivity/Allergic reaction (1907)

Event Type  Injury  

Manufacturer Narrative

As reported in a research article, a patient had chest pain, shortness of breath, residual shunt and increasing frequency and intensity of migraines after an amplatzer cribriform implant.The patient was diagnosed with a nickel allergy and the device was explanted.The instructions for use, document 600218-010 revision b warns that patients who have a nickel allergy may have a reaction to the device.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

Reference manufacturing report number:2135147-2019-00389, 2135147-2019-00388, 2135147-2019-00386, 2135147-2019-00384, 2135147-2019-00383, 2135147-2019-00382, 2135147-2019-00381.It was reported through a research article identifying amplatzer that may be related to explant of devices.Specific patient information is documented as a (b)(6) years old woman.Details are listed in the attached article, titled explantation of patent foramen ovale closure devices.On an unknown date, a 25mm amplatzer cribriform asd was implanted without difficulty.Three months post procedure, the patient experienced increase in the frequency and intensity of migraines.The patient also developed chest pain and shortness of breath.One year post procedure, the patient was diagnosed with nickel allergy and was given a treatment of clopidogrel and prednisonel.The chest pain persisted and the patient underwent surgical excision of the device.A small fenestration in the atrial septum was observed, which accounted for the residual shunt.Pathological examination revealed extensive fibrosis with scattered eosinophils and inflammatory cells.After the explantation, the chest pain resolved and the migraines reduced in frequency.

• Brand Name: AMPLATZER CRIBRIFORM 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: 9345085
• MDR Text Key: 169321336
• Report Number: 2135147-2019-00390
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P000039
• 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

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-MF-025
• Device Catalogue Number: 9-ASD-MF-025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• 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): Other; Required Intervention
• Patient Age: 49 YR