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

Catalog Number GSXE0025

Device Problem Insufficient Information (3190)

Patient Problem Thrombus (2101)

Event Date 07/24/2015

Event Type  Injury  

Event Description

It was reported the physician implanted a 25mm goree septal occluder on (b)(6), 2015.On (b)(6) 2015, the device was imaged under transthoracic echocardiography (tte).Imaging showed a well-positioned device with no abnormalities.On (b)(6) 2015, the device was imaged under tte and thrombus was seen on the right disc of the device.The thrombus measured 3.5 cm long.The patient's medical therapy was changed from aspirin to heparin.Another tte was performed the following day.The thrombus was smaller and the physician confirmed the patient was doing well.

Manufacturer Narrative

The patient had an additional transesophageal-echocardiography (tee) examination in (b)(6).The physician does not believe that there was a thrombus formation on the right disc of the occluder.He believes the images indicate that the retrieval cord broke and a piece of the cord remains attached to the right eyelet of the device.Images of the device were received by gore.An imaging evaluation is currently in progress.

Manufacturer Narrative

Additional evaluation of the echo images was conducted by the physician, comparing pre- and post-implant images.There is no evidence of any anatomical structure like a chiari network or a prominent eustachian valve in the pre-implantation images.The physician is convinced (and the images seem to support this) that there was indeed a thrombus formation.Due to medical treatment the thrombus got smaller but was still visible at the last echo examination in (b)(6).Images were received by gore for evaluation.The evaluation stated a gore septal occluder was implanted in (b)(6) 2015.In (b)(6) the device was imaged via tte with no abnormalities.In (b)(6) the device was imaged under tte and per the performing facility, a thrombus was visualized in the right atrium and appeared to be attached to the right atrial disc.On the tee imaging provided there does appear to be an object attached to the device.Without previous echo imaging from pre deployment or during deployment of the device it is difficult to ascertain the exact nature of this object.As stated there was no imaging from the implantation of the device or the follow up tte done in (b)(6) provided for comparison.The patient was medically treated by the performing facility and the device left implanted.

• Brand Name: GORE® CARDIOFORM 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 86001
• Manufacturer Contact: ashley marostica ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5022644
• MDR Text Key: 23802066
• Report Number: 2017233-2015-00546
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: Followup
• Report Date: 10/14/2015

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: 03/09/2017
• Device Catalogue Number: GSXE0025
• Device Lot Number: 13649444
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/11/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2015
• 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): Other
• Patient Age: 48 YR
• Patient Weight: 67