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

Catalog Number GSX0030A

Device Problems Malposition of Device (2616); Patient Device Interaction Problem (4001)

Patient Problems Chest Pain (1776); Pericardial Effusion (3271)

Event Date 11/01/2018

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.

Event Description

It was reported the physician selected a 30mm gore® cardioform septal occluder to close a patent foramen ovale.As the physician attempted left disc deployment, it was noted part of the disc was forming in the tunnel.The device was reloaded and repositioned; however, when attempting left disc deployment again, part of the disc was still forming in the tunnel.The device was reloaded.During this time the patient complained of chest pain.Intracardiac echocardiography showed a slight effusion in the right atrium.Doppler imaging showed more widespread effusion and the device was removed from the patient.Pericardiocentesis was performed in the cath lab and the patient had remained stable through the process.The defect was left untreated.

• 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: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 8052728
• MDR Text Key: 126589003
• Report Number: 2017233-2018-00666
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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: 11/01/2018

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: 07/22/2020
• Device Catalogue Number: GSX0030A
• Device Lot Number: 18387007
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2018
• 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): Required Intervention
• Patient Weight: 133