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

Model Number	ASD48A
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	06/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of birth: exact date of birth is unknown, as patient was born in (b)(6) will be used as date of birth.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.
Event or Problem Description
It was reported to gore a 48mm gore® cardioform asd occluder was selected to treat an atrial septal defect.The device was deployed and locked, however, when the delivery system was being pulled out, the lock loop was stuck in the slot of the catheter and the device embolized to the inferior vena cava then broke free and embolized to the pulmonary artery.A 16fr sheath was placed and the device was snared, but as it was being brought down into the sheath it broke free and embolized again to the pulmonary artery.A 24fr sheath was placed and the device was successfully snared and removed.The patient was reported to be doing well and was to be discharged the same day.The patient will be brought back at a future date for closure of the defect.
Additional Manufacturer Narrative
H6: updated investigation finding and conclusion codes.

• 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
• MDR Report Key: 12127651
• Report Number: 2017233-2021-02137
• Device Sequence Number: 3361942
• Product Code: MLV
• UDI-Device Identifier: 00733132636525
• UDI-Public: 00733132636525
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 08/02/2021

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: 03/26/2023
• Device Model Number: ASD48A
• Device Catalogue Number: ASD48A
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 08/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 28 YR
• Patient Weight: 77