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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Hypersensitivity/Allergic reaction (1907); Itching Sensation (1943)

Event Date 06/11/2018

Event Type  Injury  

Manufacturer Narrative

An event of an allergic reaction was reported.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

A patient reported complaint was received on 10 october 2018.Per patient report, on (b)(6) 2018, a amplatzer septal occluder (unknown size) was implanted.There were no reported issues during the amplatzer procedure and the device successfully sealed the hole and functioned as expected.On (b)(6) 2018, the patient sought treatment at the emergency room (er) due to itching and chest pain.At that time, it was originally thought that she was having an allergic reaction to the prescribed antibiotics.Intravenous (iv) steroids were administered and the patient was discharged from the er on the same day.The patient again sought care at the emergency room on (b)(6) 2018, and was sent home on the same day after receiving iv steroids.The patient was hospitalized from (b)(6) 2018 until (b)(6) 2018 for treatment with iv steroids.Additionally, a demonstration amplatzer device was taped to the patient¿s arm to detect possible allergic reaction.The outcome of this ¿test¿ was not made available; however, the patient reports since the aso implant she experienced migraines with aura, shortness of breath, pain, and itchiness on her upper body (i.E., upper back, chest, arms, neck and jawline) as well as some on her legs.Patient reported nickel sensitivity since the age of 16, and previous allergy tests have been performed but were negative for a nickel allergy.Patient has taken zyrtec, claritin, and liquid benadryl over-the-counter (otc) allergy medications, and has taken doctor-prescribed prednisone six times since the procedure; however, the symptoms were not reportedly resolved and otc medications were discontinued.Patient is currently being treated by her md, with possible plans to remove the aso.However, the physician would like to see positive results to allergy testing in order to confirm that her symptoms are related to an allergy.

Manufacturer Narrative

An event of an allergic reaction was reported.The results of the investigation are inconclusive since the device was not returned for analysis.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.Per the instructions for (ifu) this device contains nickel-titanium alloy, which is generally considered safe.However, in vitro testing has demonstrated that nickel is released from this device for a minimum of 60 days.Patients who are allergic to nickel may have an allergic reaction to this device, especially those with a history of metal allergies.Certain allergic reactions can be serious; patients should be instructed to seek medical assistance immediately if they suspect they are experiencing an allergic reaction.Symptoms may include difficulty in breathing or swelling of the face or throat.While data is currently limited, it is possible that some patients may develop an allergy to nickel if this device is implanted.Based on the information received, the cause of the reported incident could not be conclusively determined.

• 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: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8042608
• MDR Text Key: 126287264
• Report Number: 2135147-2018-00192
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: 10/10/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 11/19/2018
• Supplement Dates FDA Received: 11/29/2018
• 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
• Patient Age: 47 YR
• Patient Weight: 86