MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES GORE® CARDIOFORM SEPTAL OCCLUDER; TRANSCATHETER, SEPTAL OCCLUDER

Catalog Number GSX0030A

Device Problem Insufficient Information (3190)

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

Event Date 01/30/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4) the review of the manufacturing records verified that this lot met all pre-release specifications.

Event Description

It was reported to gore a gore® cardioform septal occluder was selected to close a patent foramen ovale with a long tunnel in a patient with a small left atrium.It was reported that due to the angles of the defect there was difficulty seeing the device on intracardiac echocardiography and a perforation of the left atrium occurred when unsheathing the device.A drain was placed to remove fluid from the pericardium and was removed after two days.It was reported the patients conditioned improved.The device remains implanted and the patient was discharged to home.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kathy titus ; 9285263030
• MDR Report Key: 7282090
• MDR Text Key: 100419153
• Report Number: 2017233-2018-00110
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/07/2018

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: 11/15/2019
• Device Catalogue Number: GSX0030A
• Device Lot Number: 17448995
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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: 50 YR
• Patient Weight: 99