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

Catalog Number GSXE0030

Device Problems Difficult to Remove (1528); Patient-Device Incompatibility (2682)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/11/2021

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use note that there must be adequate room in the atrial chambers to allow the right and left atrial discs to lie flat against the septum with disc spacing equal to the septal thickness, and without interference with critical cardiac structures or the free wall of the atrial.

Event Description

It was reported the physician selected a 30mm gore® cardioform septal occluder to treat an atrial septal defect balloon sized to 13mm with a deficient aortic rim.The device was placed and locked.While assessing the device with echocardiography, it was determined the occluder was too big for the patient's anatomy as it was too close to the mitral valve.The physician attempted to remove the device with the retrieval cord; however, the cord had detached from the device and pulled through.The physician opted to leave the device in place and the patient was scheduled for device removal and surgical closure the following day.The patient was doing well following surgery.

• Brand Name: GORE CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11425547
• MDR Text Key: 239428169
• Report Number: 2017233-2021-01741
• 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: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/14/2022
• Device Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2021
• Date Device Manufactured: 09/14/2020
• 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