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 03/05/2021

Event Type  Injury  

Event Description

It was reported the physician selected a 48mm gore® cardioform asd occluder to treat an atrial septal defect balloon sized to 27mm (static sizing 24mm) in a patient with deficient retro aortic and superior rims.The device was deployed, locked, and released without issue.Two to three minutes later, while assessing the device, it embolized into the right atrium.The physician's attempt to snare the device were unsuccessful and the occluder moved into the right ventricle and then to the right pulmonary artery.The patient was sent directly to surgery for device removal and surgical defect repair.

Manufacturer Narrative

Fluoroscopic images of attempted device retrieval were returned for evaluation.The images show a large sheath next to the occluder and a gooseneck snare.The snare was unable to capture the right or left atrial eyelets or the leaflets of the occluder.The gore® cardioform asd occluder instructions for use list device embolism as a potential clinical and device adverse event.

• Brand Name: GORE CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 north 4th street; flagstaff AZ 86004
• MDR Report Key: 11585763
• MDR Text Key: 243064385
• Report Number: 2017233-2021-01821
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636525
• UDI-Public: 00733132636525
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/11/2022
• Device Model Number: ASD48A
• Device Catalogue Number: ASD48A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 44 YR
• Patient Weight: 77