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

Model Number 9-ASD-016

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

Patient Problems Erosion (1750); Pericardial Effusion (3271)

Event Date 11/29/2017

Event Type  Injury  

Manufacturer Narrative

Udi: unknown since the batch/lot number is unknown.

Event Description

On (b)(6) 2005, a 16 mm amplatzer septal occluder (aso) was implanted.On (b)(6) 2017, the patient suffered a cardiac effusion and the aso was surgically removed and the patient's defect was closed.Per report, the cause of the pericardial effusion was erosion.The patient was reported to be in stable condition.

Manufacturer Narrative

An event of pericardial effusion due to erosion 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

On (b)(6) 2005, a 16 mm amplatzer septal occluder (aso) was implanted.On (b)(6) 2017, the patient was diagnosed with a cardiac effusion.The aso was surgically removed and the patient's defect was closed.Per report, the cause of the pericardial effusion was erosion.The patient was reported to be in stable condition.Abbott's multiple requests for additional information were not answered and no additional details were provided.

• 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: denise johnson ; 5050 nathan lane north; plymouth, MN 55442 ; 6517564470
• MDR Report Key: 7148932
• MDR Text Key: 95856757
• Report Number: 2135147-2017-00193
• 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: 04/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 9-ASD-016
• Device Catalogue Number: 9-ASD-016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• 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
• Patient Age: 15 YR
• Patient Weight: 65