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

Model Number	ASD37A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician selected a 37mm gore® cardioform asd occluder to treat an atrial septal defect with a static measurement of 23mm x 24mm (balloon sizing was not performed) and a septal length of 34mm x 47mm.The occluder was deployed and locked with good septal apposition.A minor residual shunt was noted.The following day, imaging showed the occluder had embolized to the left pulmonary artery.This device was snared and a 44mm gore® cardioform asd occluder was implanted with no adverse effects.The patient was doing well following the procedure.
Additional Manufacturer Narrative
The gore® cardioform asd occluder instructions for use list device embolization as a potential clinical and device adverse event.

• 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13667066
• Report Number: 2017233-2022-02784
• Device Sequence Number: 5466467
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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): 03/04/2022

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: 10/04/2024
• 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): Initial
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/04/2022
• Date Device Manufactured: 10/06/2021
• 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: Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male
• Patient Weight: 73 KG