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

Model Number ASD37A

Device Problems Inadequacy of Device Shape and/or Size (1583); Migration (4003)

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

Event Date 03/04/2021

Event Type  Injury  

Event Description

It was reported the physician selected a 37mm gore® cardioform asd occluder to treat an atrial septal defect balloon sized to 17mm in a patient with a deficient retro-aortic rim, measuring 2.3mm.The device was placed without issue; however, after the device was released, a residual shunt was noted.The physician used a 20fr.Dryseal sheath and a snare to attempt device retrieval.During retrieval, the occluder could not be brought into the sheath and embolized to the tricuspid valve.Additional attempts to snare the device from both the groin access and the internal jugular were unsuccessful and the patient was sent directly to surgery for device removal.The patient was doing well following surgery.

Manufacturer Narrative

Only the occluder was returned to gore for analysis.The investigation revealed that the occluder was locked with the lock loop through all three eyelets.The size and shape of the occluder and lock loop were unremarkable.The cause of the residual shunt, difficulty retrieving the occluder, and embolization are unknown and cannot be determined from the evidence available.Echocardiography images were returned to for evaluation.The defect appears to be balloon sized appropriately.The rims of the defect superiorly, posteriorly and inferiorly look sufficient enough to support the device implanted.When deploying the device it appears that the anterior portion of the left disc did not wrap around the aorta and slipped through onto the right side of the septum.There also appears to be a small residual shunt coming around the device anteriorly; however, the device is very deformed from the tension of delivery system.It is unclear from the imaging provided if this resolved before the locking loop was released.The device is then visualized much flatter on the septum.This appearance is consistent with the locking loop being released and tension from the delivery system removed.It is unclear from the imaging when the retrieval suture was removed.The device appears to have captured the posterior, superior and inferior tissue successfully; however, the anterior portion of the left disc appears to have slipped through the defect.With the left anterior disc not wrapped around the aorta and on the right side of the septum a clear residual shunt by the aorta is visualized.The gore® cardioform asd occluder instructions for use (ifu) list device embolization as a potential clinical and device adverse event.Additionally, the ifu also advises removal of the device if the selected occluder will not come to rest in a planar position apposing the septal tissue or allows excessive shunting.Code 1583 was incorrectly added as a medical device problem code on the initial report.

• 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: 11584586
• MDR Text Key: 242816566
• Report Number: 2017233-2021-01820
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• 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: 04/21/2021

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: 08/21/2023
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/15/2021
• Date Manufacturer Received: 03/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 16 YR
• Patient Weight: 83