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

Catalog Number GSX0020A

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

Patient Problems Headache (1880); Thrombus (2101)

Event Date 10/25/2016

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).

Event Description

It was reported a physician implanted a 20mm gore cardioform septal occluder to close a patent foramen ovale on (b)(6) 2015 to treat chronic migraines.The headaches resolved post closure.Recently, the patient presented with headaches and the device was imaged.Echocardiography showed no visible shunting; however, a thrombus formation was seen on the right atrial disc.The patient had not been on antiplatelet therapy since 6 months after the implant and is now being treated with anticoagulants.

Manufacturer Narrative

Based on additional information received by gore, fields have been updated to (b)(6) 2016.Echocardiographic images (performed (b)(6) 2016) were received by gore for evaluation.Based on the images provided, thrombus formation on the gore cardioform septal occluder cannot be confirmed.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: OCCLUDER, TRANSCATHETER SEPTAL
• 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: 6103740
• MDR Text Key: 59973666
• Report Number: 2017233-2016-00871
• 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,Followup
• Report Date: 02/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2017
• Device Catalogue Number: GSX0020A
• Device Lot Number: 14197780
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2015
• 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 Age: 20 YR
• Patient Weight: 68