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

Model Number ASD44A

Device Problem Migration (4003)

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

Event Date 04/02/2021

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 44mm gore® cardioform asd occluder to treat an atrial septal defect balloon sized to 22mm with a deficient retro-aortic rim.The device was deployed, locked, and released without issue.During device assessment, the occluder embolized into the right atrium.The physician attempted to recapture the device with a snare; however, the right atrial eyelet was stuck on the tricuspid valve, and the patient was sent to surgery for defect closure and device removal.The patient was doing well following the procedure.

Manufacturer Narrative

Echocardiographic and fluoroscopic images were received for evaluation.The images show the retro aortic rim is totally deficient.The posterior rim appears adequate and the superior rim appears to be somewhat deficient.Further images show that following device locking and release, the device appears to not be evenly deployed on the atrial septum.From the echocardiography imaging, a portion of the left disc does appear to be prolapsed through the defect onto the right atrial side at approximately the retro aortic/superior rim location.The lack of tissue capture may have contributed to the embolization 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
• MDR Report Key: 11754071
• MDR Text Key: 250005155
• Report Number: 2017233-2021-01930
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2022
• Device Model Number: ASD44A
• Device Catalogue Number: ASD44A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR
• Patient Weight: 65