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

Model Number GSX0030A

Device Problem Patient Device Interaction Problem (4001)

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

Event Date 10/05/2020

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use includes but is not limited to the following potential device or procedure-related adverse events associated with the use of the occluder: pericardial tamponade and significant pleural or pericardial effusion requiring drainage.

Event Description

The following information was obtained through the clinical study (b)(6): it was reported the physician implanted a 30mm gore® cardioform septal occluder on (b)(6) 2020.Cardiac tamponade was reported the same day and a pericardial drain was placed.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 10742047
• MDR Text Key: 213260063
• Report Number: 2017233-2020-01384
• 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: 10/27/2020

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: 11/10/2021
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/06/2020
• Initial Date FDA Received: 10/27/2020
• Date Device Manufactured: 11/11/2019
• 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: 66 YR
• Patient Weight: 63