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

Model Number	ASD37A
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Foreign Body Embolism (4439)
Date of Event	03/03/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to gore a 37mm gore® cardioform asd occluder was implanted on (b)(6) 2022 to treat an atrial septal defect.The physician reported on (b)(6) 2022 that the device had embolized to the left pulmonary artery.No further information was provided.The patient was taken to the catheterization lab for retrieval of the device; however, the attempt to retrieve the device was unsuccessful and the patient was taken to surgery.Update provided from the physician.The patient is doing fine after the surgery.
Additional Manufacturer Narrative
As the date the embolization occurred is unknown at this time, the date gore aware (b)(6) 2022 is being used as the date of event.Requested patient weight, but is unknown.Imaging evaluation: from the fluoroscopy imaging provided the device appears to be in an unstable position on the atrial septum.However, without echocardiography, this cannot be confirmed.There does appear to be adequate tissue in between the posterior/inferior portions of the disc.The anterior/superior discs appear very flat indicating inadequate tissue in between the left and right discs.In the images and videos provided the device does not appear stable at the time of locking or releasing.The left and right discs are moving simultaneously as opposed to the proper motion of moving away from each other.This is indicative of an instable device.When going through the checklist for releasing gore cardioform asd occluder, it is noted in the checklist to make sure there is clear disc separation between the left and right disc in the lao/cra views.Without further imaging, it cannot be determined if the device had clear disc separation to leave the device in at the time of implant.The gore® cardioform asd occluder instructions for use states: potential clinical and device adverse events associated with the use of the occluder may include, but are not limited to: device embolization.
Additional Manufacturer Narrative
H6: updated clinical code to 4439.Updated impact code to 4627 and 4624.Updated medical device problem code to 4003.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13801891
• Report Number: 2017233-2022-02809
• Device Sequence Number: 19859781
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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,Followup
• Report Date (Section B): 04/27/2022

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: 09/27/2024
• 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: 03/03/2022
• Supplement Date Received by Manufacturer: 03/03/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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; Hospitalization
• Patient Age: 56 YR
• Patient Sex: Male