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

Device Problems Difficult to Remove (1528); Material Separation (1562); Inadequacy of Device Shape and/or Size (1583); Migration (4003); Physical Resistance/Sticking (4012)

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

Event Date 04/15/2021

Event Type  Injury  

Event Description

It was reported to gore a 32mm gore® cardioform asd occluder was selected to treat an atrial septal defect.The device was deployed; however, a small residual shunt was noted and the physician decided to remove the device.The physician states he was too aggressive when he felt resistance in attempting to remove the device and the retrieval cord broke.When attempting to retrieve the device by snare through a 14f sheath, it appeared that it was being pulled by only one wire and it looked like the device was coming apart.The device embolized into the left atrium and was then snared and removed without any harm to the patient.A second 32mm gore® cardioform asd occluder was successfully implanted.

Manufacturer Narrative

H6: updated investigation findings-code 213 the engineering evaluation revealed that the occluder wire frame was damaged and frame wires were exposed as received by gore.This can likely be attributed to the snaring process.If the occluder was not secured to the snare it is further possible for the occluder to release from the snare and embolize, as in this case.The size and shape of the occluder were unremarkable.The occluder eyelets were unremarkable (i.E.No exposed eyelet wires or insufficient eyelet trim).The delivery system and retrieval cord were not returned for analysis.It is possible that excessive force applied during device retrieval caused the retrieval cord to break.The cause of the residual shunt, difficulty retrieving the device, broken retrieval cord, and device embolism is unknown and cannot be determined from the evidence available.H6: updated investigation conclusions codes the gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: device embolization.

• 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: 11819214
• MDR Text Key: 250443875
• Report Number: 2017233-2021-01993
• Device Sequence Number: 1
• Product Code: MLV
• 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: 05/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2021
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 4 YR
• Patient Weight: 17