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

Model Number ASD48A

Device Problem Migration (4003)

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

Event Date 11/18/2021

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform asd occluder instructions for use list device embolization as a potential clinical and device adverse event.

Event Description

It was reported the physician selected a 48mm gore® cardioform asd occluder to treat an atrial septal defect balloon sized to 30-32mm.Following deployment, both fluoroscopic and transesophageal (tee) imaging showed equal deployment of the left and right discs on their respective sides of the septum.The device was then locked, and after further imaging review showed the device well positioned, the retrieval cord was removed.After removal of the retrieval cord there was some question about the appearance of one of the left petals on tee, so the physician decided to further interrogate using intracardiac echocardiography (ice).Before the ice catheter could be advanced into place, the device prolapsed completely into the right atrium.The physician attempted to remove the device with a snare; however, the attempt was unsuccessful as the device had shifted into the tricuspid valve and was sitting in both the right atrium and right ventricle.The physician felt that device closure was not going to be possible due to the patient's anatomy, so a surgeon was alerted and the decision was made to take the patient to the operating room for device removal and surgical defect repair.The physician later reported that the device was removed safely with no damage to the tricuspid valve and the atrial septal defect was surgically closed with no adverse effects.

• 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12991088
• MDR Text Key: 282198701
• Report Number: 2017233-2021-02609
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636525
• UDI-Public: 00733132636525
• 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: 12/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/22/2023
• Device Model Number: ASD48A
• Device Catalogue Number: ASD48A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2021
• Date Device Manufactured: 01/23/2020
• 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
• Patient Age: 16 YR
• Patient Sex: Female
• Patient Weight: 70 KG