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

Model Number 9-ASD-018

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Perforation (2513)

Event Date 10/27/2017

Event Type  Injury  

Manufacturer Narrative

An event of a 2mm laceration "on the roof of the left atrium," and pericardial effusion 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.Based on the information received, the cause of the reported incident could not be conclusively determined.

Event Description

An 18mm amplatzer septal occluder (aso) was successfully implanted to occlude an anterior and superior defect with a 10f amplatzer torqvue 45 delivery system (lot: 5615088) and a 34mm amplatzer sizing balloon ii(lot: 5767076).Eight hours post-procedure the patient referred sickness.A tte was performed and showed a pericardial effusion.The patient underwent cardiac surgery and a 2mm laceration was seen on the roof of the left atrium which was sutured with glow.The aso remains implanted.The patient is reported to be recovering.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Type of Device: CARDIAC OCCLUSION DEVICE
• 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: 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 7048219
• MDR Text Key: 92606062
• Report Number: 2135147-2017-00158
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P000039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Model Number: 9-ASD-018
• Device Catalogue Number: 9-ASD-018
• Device Lot Number: 5272956
• Other Device ID Number: 00811806010151
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/21/2015
• 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): Required Intervention