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

Model Number 9-PFO-035

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

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

An event of a 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

A 35 mm amplatzer pfo occluder was successfully implanted (b)(6) 2017.The procedure was without issues, however, the patient complained of chest pain throughout the night.On (b)(6) 2017, an echocardiogram revealed a pericardial effusion/tamponade which required a pericardiocentesis that was performed in the cath lab.It was determined that a laceration of the proximal ascending aorta and free wall of the left atrium was the source of the bleeding and it was surgically corrected.The pfo occluder was left in place and small pledgeted sutures successfully closed the area of the bleeding.The patient is recovering in the icu and is expected to make a complete recovery with no future complications.

• Brand Name: AMPLATZER PFO 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: 7147149
• MDR Text Key: 95793081
• Report Number: 2135147-2017-00190
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P120021
• 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
• Report Date: 12/26/2017

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
• Device Expiration Date: 05/31/2022
• Device Model Number: 9-PFO-035
• Device Catalogue Number: 9-PFO-035
• Device Lot Number: 6026009
• Other Device ID Number: 00811806011301
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2017
• Initial Date FDA Received: 12/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2017
• 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: 36 YR
• Patient Weight: 56