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

Catalog Number GSX0030A

Device Problem Fracture (1260)

Patient Problems Cardiac Tamponade (2226); Cardiac Perforation (2513); Foreign Body In Patient (2687)

Event Date 05/06/2017

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation, and a device lot number was not provided; therefore, an investigation was unable to be performed and a cause of the reported event was unable to be determined.

Event Description

It was reported a gore helex septal occluder was implanted in a patient in early 2015.On (b)(6) 2017, the patient was found in cardiac tamponade and admitted through the emergency room to the hospital¿s cath lab.Echocardiographic images demonstrated a large shunt from the aorta to the right side of the heart.Pericardiocentesis was performed and the patient stabilized.Follow-up cardiac angiographic computed tomography imaging was scheduled.On (b)(6) 2017, the patient underwent surgery and the helex device was explanted.It was further reported that the right atrial disc was fractured and had punctured through the right atrial free wall and into the aorta.The patient was stable following surgery.

Manufacturer Narrative

Additional information received indicates the device is a gore® cardioform septal occluder, not a gore® helex® septal occluder, as originally reported.The gore® cardioform septal occluder instructions for use note that potential device or procedure-related adverse events may include device fracture resulting in clinical sequelae or surgical intervention.Also, additional information received notes the device was used to close a patent foramen ovale.The gore® cardioform septal occluder indications/intended use state "the gore® cardioform septal occluder is a permanently implanted device indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (asds).".

Manufacturer Narrative

Gore® cardioform septal occluder, (b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

Article citation: kumar p, orford jl, tobis jm.Two cases of pericardial tamponade due to nitinol wire fracture of a gore septal occluder.Catheter cardiovasc interv.2019;1¿6.Https://doi.Org/10.1002/ccd.28596.Added information: (b)(6), date of birth (b)(6) 1963.Lot #14116730; expiration date 7/26/2017; unique identifier # (b)(4).Corrected information: catalog # gsx0030a.

• 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: 6581740
• MDR Text Key: 75652934
• Report Number: 2017233-2017-00269
• 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: 03/03/2020

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: 07/26/2017
• Device Catalogue Number: GSX0030A
• Device Lot Number: 14116730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/22/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 09/11/2017; 09/21/2017; 02/18/2020; 03/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/27/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 54 YR