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

Catalog Number GSXE0030

Device Problems Patient-Device Incompatibility (2682); Insufficient Information (3190)

Patient Problems Pleural Effusion (2010); Cardiac Tamponade (2226)

Event Date 07/25/2018

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® cardioform septal occluder instruction for use adverse events associated with the use of the septal occluders may include, but are not limited to pericardial tamponade and significant pleural or pericardial effusion requiring drainage.

Event Description

The following was reported to gore: the patient presented with a patent foramen ovale (pfo), which was intended to be treated with a gore® cardioform septal occluder.The septum shows a large aneurysm with a stiff tunnel.After several unsuccessful attempts to conform the left disc, a cardiac tamponade was observed.The physician abrupt the procedure and did a pericardiocentesis.The patient is doing well following the procedure.

• 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: ruth kunzmann ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7776120
• MDR Text Key: 116857276
• Report Number: 2017233-2018-00500
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: GSXE0030
• Device Lot Number: 18072167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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; Other
• Patient Age: 54 YR
• Patient Weight: 51