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

Model Number ASD37A

Device Problem Break (1069)

Patient Problem Obstruction/Occlusion (2422)

Event Date 07/22/2021

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: device embolization.

Event Description

It was reported to gore a 37mm gore® cardioform asd occluder was selected to treat an atrial septal defect.It was reported the retrieval cord broke for some reason (very little force on it, i usually make sure everything is coaxial and do not pull with too much force when pulling on the cord).The device embolized to the left atrium/left ventricle.The device was able to be snared out and a second 37mm gore® cardioform asd occluder was implanted.It was reported the patient was doing well.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12553968
• MDR Text Key: 274033813
• Report Number: 2017233-2021-02420
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• 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: 09/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/11/2021
• Date Device Manufactured: 12/01/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 11 YR
• Patient Weight: 30