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

Catalog Number GSXE0030

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

Patient Problems Fever (1858); Thrombus (2101)

Event Date 10/22/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing and sterilizations records verified the lot was processed normally and all pre-release specifications were met.The gore® cardioform septal occluder instructions for use list device thrombosis or thromboembolic event resulting in clinical sequelae as a potential device- or procedure related adverse event.

Event Description

It was reported the physician successfully implanted a 30mm gore® cardioform septal occluder to close a patent foramen ovale on (b)(6) 2019.Following closure the patient developed a fever (39° celsius).Transesophageal echocardiography examination a few hours after implantation showed unusual structures on the surfaces of the left and right atrial discs, which suggested thrombus formation.The fact that the thrombus was spread over the surfaces of both discs suggested that the patient suffered from endocarditis.The patient was anti-coagulated with falithrom.On (b)(6) 2019, follow-up transesophageal echocardiography showed no signs of thrombus formation.After the follow up examination the physician is inclined to rule out endocarditis, yet is confused about the thrombus formation on both discs in a relatively short amount of time.

• 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: 9459672
• MDR Text Key: 185072275
• Report Number: 2017233-2019-01241
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Catalogue Number: GSXE0030
• Device Lot Number: 20233917
• 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: 02/13/2019
• 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): Other; Required Intervention