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

Catalog Number	ASD44A
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	Pericardial Effusion (3271)
Date of Event	10/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The gore® cardioform asd occluder instruction for use note perforation of a cardiovascular structure by the device as a potential device or procedural related adverse event.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
Event or Problem Description
It was reported the physician selected a 44mm gore® cardioform asd occluder to treat an atrial septal defect, measured to 18mm x 26mm by 3d.The defect was not balloon sized due to the physician's concern of tearing septal tissue.Intracardiac echocardiography was used during the procedure.The first and second deployment attempts were not successful in capturing the retro aortic rim, as the occluder prolapsed.The device was removed and the physician manually formed a larger bend on the distal end of the delivery system.The device was then reintroduced with a j guidewire.Upon deploying the right atrial disc, a pericardial effusion was noted.30mg/ml of protamine was initiated.The device was locked and assessed for adequate coverage and the retrieval cord was removed.The pericardial effusion was drained.An additional 20mg/ml of protamine was administered.1.5 l of blood was drained.30 additional units of protamine was given.The device appeared stable with no color noted around occluder.The patient was stable and sent to cicu for monitoring.Blood was to be given on the floor.
Additional Manufacturer Narrative
Case imaging was provided for evaluation.A gore® cardioform asd occluder can be visualized.It appears that the device is in a locked and released position but that cannot be confirmed without additional imaging.With the images provided, the cause of the pericardial effusion cannot be determined.

• 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: 17986413
• Report Number: 2017233-2023-04349
• Device Sequence Number: 12808303
• Product Code: MLV
• UDI-Device Identifier: 00733132636518
• UDI-Public: 00733132636518
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/15/2023

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: 01/30/2026
• Device Catalogue Number: ASD44A
• 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: 10/06/2023
• Supplement Date Received by Manufacturer: 10/06/2023
• Initial Report FDA Received Date: 10/23/2023
• Supplement Report FDA Received Date: 11/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 80 KG