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

Model Number GSX0030A

Device Problem Stretched (1601)

Patient Problem No Code Available (3191)

Event Date 12/28/2020

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform septal occluder instructions for use states: removal of the occluder should be considered if: the lock loop does not capture all three eyelets.Patient weight not available.

Event Description

It was reported the physician implanted a 30mm gore® cardioform septal occluder to close an atrial septal defect on (b)(6) 2020.Slight right disc expansion was noticed.The lock loop was still capturing the right eyelet and the device was stable and not obstructing any cardiac structures, so the device was left implanted.On (b)(6) 2020, the patient was evaluated again, and the lock loop had come off the right eyelet.The device was still in good position with no significant shunt.The patient has a history of heart failure and a large left to right shunt.This occluder was implanted during a mitral clip procedure.The patient had the device surgically removed and repaired with a patch on (b)(6) 2021.The surgeon also repaired the mital and tricuspid valve.The patient was doing well following the 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: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11195293
• MDR Text Key: 227574895
• Report Number: 2017233-2021-01611
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2021
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2020
• Date Device Manufactured: 05/07/2019
• 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): Other
• Patient Age: 82 YR