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

Model Number	ASD44A
Medical Device Problem Codes	Fracture (1260); Device Slipped (1584)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	10/28/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported the physician successfully implanted a 44mm gore® cardioform asd occluder on (b)(6) 2019 to treat an atrial septal defect measured to 20 x 23mm.The patient was lost to follow-up; however, on an unknown date in 2021, the patient experienced a stroke.Imaging confirmed a device-related shunt and it was suspected the device had slipped on the septum.The patient was sent to another hospital where a surgeon explanted the occluder and closed the atrial septal defect with a patch on (b)(6) 2021.
Additional Manufacturer Narrative
Echocardiographic case images were returned to w.L.Gore & associates for evaluation.The images reveal a portion of the occluder had prolapsed into the right atrium.A residual shunt was visualized near the superior vena cava and the aorta where the occluder had lost capture of the atrial tissue.The device was returned to w.L.Gore & associates for analysis.Gross and microscopic examination of the tissues covering the gore® cardioform asd occluder was performed.Histopathology analysis: the tissue was consistent with bland mature dense collagen regionally covered by neoendocardium.White tissue stalks emanating from the lock loop were composed of similar collagenous tissue with embedded clumps of smooth muscle cells.There was no evidence of inflammation or thrombus.The tissue would be considered normal healing tissue response to a chronically implanted device.The device was subjected to an enzymatic digestion process to remove biologic debris.Following digestion, the device was examined for material disruptions with the aid of a stereomicroscope.13 total holes were present on the right and left disc, which were likely caused by interaction with surgical instrumentation or wire discontinuity interaction.On the left disc side, a total of eight wire discontinuities were present.The examined wire discontinuities exhibited topological characteristics that are indicative of fatigue overloading or fracture.No evidence of corrosion, abnormal abrasion, or material irregularities were observed on the nitinol wire.The gore® cardioform asd occluder instructions for use note that stroke, device fracture resulting in clinical sequelae or surgical invention, and intervention for device failure or ineffectiveness are potential clinical and device adverse events.

• 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: 12810736
• Report Number: 2017233-2021-02536
• Device Sequence Number: 12524136
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• 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): 04/25/2022

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: 07/11/2022
• Device Model Number: ASD44A
• Device Catalogue Number: ASD44A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/29/2021
• Supplement Date Received by Manufacturer: 10/29/2021
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 04/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2019
• 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: 45 YR
• Patient Sex: Female