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

Model Number	ASD37A
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157); Device Dislodged or Dislocated (2923); Migration (4003)
Health Effect - Clinical Code	Foreign Body Embolism (4439)
Date of Event	08/31/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient weight is unknown.
Event or Problem Description
It was reported, the physician was implanting a 37mm gore® cardioform asd occluder to close a 17mm atrial septal defect (asd) with deficient rims.The device was placed and in good position, except it was hitting on the mitral valve.The physician chose to remove the device.The physician could not get the right disc to pull into the delivery catheter.With further manipulation, the retrieval cord broke.A snare was used to try to capture the device, but it was dislodged off the septum and embolized to the pulmonary artery.The device was snared, and part of the device was able to be captured into a 16 x 65 sheath.A balloon was used to pull the device 85% of the way into the sheath, but the physician was not able to pull it in any further.The physician did not want to pull the device with part of the left disc hanging out through the valves and other vasculature, so the patient was taken to surgery to remove the device and repair the asd.The patient was doing well following the procedure.

• 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
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15428682
• Report Number: 2017233-2022-03322
• Device Sequence Number: 12690023
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2022

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: 05/02/2025
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/31/2022
• Initial Report FDA Received Date: 09/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 6 YR
• Patient Sex: Male