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

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

Patient Problems Chest Pain (1776); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969)

Event Type  Injury  

Manufacturer Narrative

Udi: unknown since batch number was not provided.(b)(4).The results of the investigation are inconclusive since the device was not returned for analysis.A review of the device history record was not possible since the lot number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The following information comes from "the journal of the japanese society of cardiovascular anesthesiologists" 2016, vol.20, suppl, page 322 (ep-2-19-4); article, "four cases of st segment elevation during deployment of amplatzer septal occluder (aso)" (available only in japanese).We obtained this information through a weekly document retrieval service from an outsourcing company.Since 2006, amplatzer septal occluder (aso) deployment were performed under general anesthesia in 444 cases at this hospital.Intraoperatively, all patients were monitored through measuring electrocardiogram by limb lead (i to iii, avl, avr and avf induction) and chest lead (v1, v5 induction), and atrial blood pressure.Four of 444 cases, st segment elevation was confirmed in the areas of ii to iii and avf induction.Cardiopulmonary resuscitation was eventually required in one case (case 1).Case 1: an aso deployment was performed.Intraoperatively, st segment was elevated, then circulatory failure and complete atrioventricular block were confirmed as well.A cardiac massage was applied and adrenaline was administered for the treatment.Although the st segment improved, the deployment procedure was aborted.About 2 years after the initial procedure, an aso deployment was performed again and an aso (model and serial/lot unknown) was successfully implanted in the patient's atrial septal defect (asd) with no issues.Case 2: an aso deployment was performed.Intraoperatively, st segment was elevated and circulatory failure was confirmed.Furthermore, the patient presented with chest pain and low blood pressure.After intravenous fluids and vasopressors were administered for the treatment, st segment improved.The aso (model and serial/lot unknown) was successfully implanted with no further issues.Case 3 and case 4: during the aso deployment, st segment elevation lasted for a few minutes in case 3 and case 4.However, they spontaneously became normal without any treatment.The asos (model and serial/lot all unknown) were successfully implanted in the respective patients and the both procedures were completed with no further issues.Three of these 4 cases, st segment elevation reportedly occurred during insertion of the guidewire into lupv (the left upper pulmonary vein) in order to measure the patient's defect with sizing balloon by using stop-flow technique.However, which cases corresponding to this issue were not indicated in article.Due to st segment elevation in the areas of ii to iii and avf induction, ischemia was considered to be observed from inferior cardiac wall led to air embolism or thromboembolic obstruction in the area supplied by right coronary artery (rca).Less commonly, as this kind of case is likely to cause failure of circulatory dynamics, the physician should pay careful attention to conducting catheter intervention for the treatment of asd.There was no information available other than we reported about the patient, the date of the procedure, the reported devices (model, serial and lot number) and the patient's preoperative/postoperative condition in respective cases.No additional information is available.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6197451
• MDR Text Key: 63066016
• Report Number: 2135147-2016-00131
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• 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
• Date Manufacturer Received: 11/29/2016
• 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; Required Intervention