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

Catalog Number HX1530

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Thrombus (2101); Therapeutic Response, Decreased (2271)

Event Date 02/24/2014

Event Type  Injury  

Event Description

A patient reported having a gore helex septal occluder implanted on (b)(6) 2010 to close a patent foramen ovale.A follow-up visit on (b)(6) 2010 noted a thrombus on a disc.The patient was prescribed blood thinners.3d transesophageal echocardiography was performed at a follow-up on (b)(6) 2010, and no thrombus was noted.At a follow-up on (b)(6) 2014, imaging showed movement in the right atrial disc and a residual shunt.The left atrial disc appeared well apposed with good tissue ingrowth.Imaging performed in (b)(6) 2014 noted shunting and the right disc was not well apposed, but the device appeared stable.No additional follow-up was recommended.

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.Images have been received for analysis and the investigation is ongoing.

Manufacturer Narrative

Imaging evaluation summary: initial implant procedure ((b)(6) 2010) intracardiac echocardiography images showed normal cardiac structures with a chiari network branching off of the eustachian ridge in the right atrium.A patent foramen ovale was assessed and a small shunt was observed.A 30mm gore® helex septal occluder was implanted with good results.On (b)(6) 2010 the patient had transthoracic echocardiography performed.Imaging revealed good disc apposition throughout the anterior superior sections of the aorta.The right disc was slightly flared near the end of the aortic root, possibly conforming to the septal anatomy.Flow was observed between the right disc and the septum, but color doppler did not reveal shunting through the discs.In the superior vena cava view, a section of the right disc was extending into the right atrium.A thread-like structure was observed extending toward the inferior section of the right disc, possibly pulling on the disc and causing it to flare.The superior edge of the left disc was slightly lifted.Bubble studies were performed at rest and valsalva.At rest, no bubbles were observed in the left atrium.When valsalva was performed, a few bubbles were observed in the left atrium.Additional echocardiography was performed on (b)(6) 2010, (b)(6) 2011.During these follow-up examinations no changes to the device appearance were observed, no shunt was detected with color flow, no bubbles were detected at rest, and a few bubbles were noted when valsalva was performed.On (b)(6) 2014 echocardiography was performed.Imaging revealed the gore® helex septal occluder remained in the same position with little to no observable changes in the appearance of the discs.The superior edge of the left disc remained lifted with suboptimal apposition.The right disc remained flared at the aortic level and at the superior vena cava level, where the disc was extending into the right atrium.The right disc appeared stable and did not appear to be mobile.A bubble study at rest remained negative.A bubble study with valsalva performed showed additional bubbles in the left atrium as compared to the previous examination.The right disc extending into the right atrium may be attributed to septal anatomy, such as chiari tissue interference with the device, or a possible frame fracture.Fluoroscopy images were not provided; therefore, a frame fracture cannot be confirmed.

• Brand Name: GORE HELEX 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 86001
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 3776695
• MDR Text Key: 4437689
• Report Number: 2017233-2014-00221
• 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: Patient
• Type of Report: Initial,Followup
• Report Date: 05/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2012
• Device Catalogue Number: HX1530
• Device Lot Number: 7614159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2010
• 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: 31 YR
• Patient Weight: 66