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

Catalog Number HX2025

Device Problem Insufficient Information (3190)

Patient Problems Endocarditis (1834); Thrombus (2101)

Event Date 07/04/2014

Event Type  Injury  

Event Description

It was reported the physician implanted a 25mm gore helex septal occluder to close a patent foramen ovale on (b)(6) 2012.On (b)(6) 2014 the patient presented with endocarditis.Transesophageal echocardiography showed thrombus formation on both the left and right side of the device.On (b)(6) 2014 the device was surgically removed.

Manufacturer Narrative

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

Manufacturer Narrative

A cd containing echocardiographic images was received for review.Transthoracic echocardiography performed on (b)(6) 2014 revealed an echo dense mass located on the gore helex septal occluder.Further evaluation by transesophageal echocardiography on (b)(6) 2014 demonstrated the echo dense mass was attached to the right and left disc of the occluder.The echo dense masses were mobile and irregular in size.The masses covered most of the right and left discs and extended close to the mitral and tricuspid valves.On (b)(6) 2014, the patient was sent to surgery to have the occluder and the echo dense masses removed and the septum repaired with a surgical patch.According to the imaging analysis, the thrombus was first noted (b)(6) 2014.The initial reports has the date of event as (b)(6) 2014.

Manufacturer Narrative

A review of the sterilization records verified this lot met pre-released specification requirements.

Manufacturer Narrative

(b)(4).These corrections do not affect the manufacturing evaluation.The correct records were reviewed originally, and the review verified the lot was processed normally and all pre-release specifications were met.

Manufacturer Narrative

The explanted device and associated cardiac septum was returned for analysis.Histopathological examination of three tissue specimens were performed.A moderately thick mature collagenous neointima diffusely covered the surface of the left disc.The right disc was multifocally covered in neointima with areas of disc material exposed.Scanning electron microscopy was unable to confirm the presence of significant endothelialization of both the right and left disc surfaces.Neointima covering the left disc and hyperplastic intima of the cardiac septum were multifocally degraded and infiltrated by inflammatory cells, particularly neutrophils.Variably sized colonies of gram positive bacterial cocci colonized the device and cardiac tissue, with the right disc more severely affected.The device was subjected to an enzymatic digestion process to remove biologic debris.Following digestion the device was examined for material disruptions with the aid of a stereomicroscope.No wear related disruptions were identified.The physician stated he believed the endocarditis was a result of patient lifestyle and drug abuse; not device related.

• 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: 3958435
• MDR Text Key: 4556637
• Report Number: 2017233-2014-00373
• 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,Followup,Followup,Followup
• Report Date: 01/26/2015

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: 01/31/2014
• Device Catalogue Number: HX2025
• Device Lot Number: 8787173A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/25/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/17/2014; 01/23/2015; 02/04/2015; 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2012
• 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: 35 YR
• Patient Weight: 82