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

Catalog Number ASD44E

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Mitral Valve Insufficiency/ Regurgitation (4451); Tricuspid Valve Insufficiency/ Regurgitation (4453)

Event Date 03/30/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all prerelease specifications.Engineering evaluation could not be performed as the device was not returned.

Event Description

It was reported to gore that a 44mm gore® cardioform asd occluder was intended to be used to treat a patient with an atrial septal defect (asd) with no aortic rim.The device was implanted on (b)(6) 2021 and was surgically explanted 24 hours after, as it was too big for the small heart of the patient and the mitral and tricuspid valves had problems.It was reported that the device was perfect, but too large for the patient.The asd was surgically closed during the explant of the device.

• Brand Name: GORE CARDIOFORM ASD 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11918481
• MDR Text Key: 265892002
• Report Number: 2017233-2021-02046
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/04/2022
• Device Catalogue Number: ASD44E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2019
• 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
• Patient Age: 6 YR
• Patient Weight: 18