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

Model Number	ASD44A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® cardioform asd occluder instructions for use list device embolization as a potential clinical and device adverse event.
Event or Problem 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.
Additional 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
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11754071
• Report Number: 2017233-2021-01930
• Device Sequence Number: 3778370
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

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