MAUDE Adverse Event Report: AGA MEDICAL CORPORATION AMPLATZER SEPTAL OCCLUDER

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

Patient Problem Pulmonary Edema (2020)

Event Type  Injury  

Manufacturer Narrative

Unknown since the batch/lot 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 serial number was unavailable.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

The information comes from the abstract titled "comparison of clinical outcomes after transcatheter vs.Minimally invasive cardiac surgery closure for atrial septal defect" from the "circulation journal" vol.81, no.4, 2017.Page 543-551.Summary: the success rate was 98% for the percutaneous group and 100% for the mics (minimally invasive cardiac surgery) group.A comparison between these two groups showed no significant differences.Minor complications in the mics group have a significantly higher incidence rate than in the percutaneous group.This study showed that percutaneous closure of atrial septal defect (asd) can be considered as the first therapeutic option for the patient with a suitable anatomy whereas there are anatomical limitations.In this single-center retrospective study between 2000 and 2013, percutaneous asd closure using amplatzer septal occluder (aso) was conducted in 134 patients between 2011 and 2013.There were adverse events after the procedure in 2 patients reported: this case of pulmonary edema requiring intravenous diuretics as major complications (per (b)(4)) and another case of anemia requiring blood transfusion as minor complications (per (b)(4)).No additional information is available.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 6629761
• MDR Text Key: 77233798
• Report Number: 2135147-2017-00064
• 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: Physician
• Type of Report: Initial
• Report Date: 06/09/2017

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
• Initial Date Manufacturer Received: 05/16/2017
• Initial Date FDA Received: 06/09/2017
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention