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

Model Number ASD32A

Device Problems Difficult or Delayed Positioning (1157); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pericardial Effusion (3271)

Event Date 07/07/2022

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform asd occluder instructions for use includes but is not limited to the following potential device or procedure-related adverse events associated with the use of the occluder: significant pleural or pericardial effusion requiring drainage.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 Description

It was reported the physician was implanting a 32 mm gore® cardioform asd occluder to close an atrial septal defect.The defect measured 13-15 mm.The device was placed and looked good on fluoroscopy but imaging with transesophageal echocardiography (tee) was very poor.The device was repositioned several times.The tee images were not good enough to get a good view, so the probe was switched for a larger one.The device was removed and re-flushed and before it was attempted again, a pericardial effusion was noted.A pericardiocentesis was performed to remove 60 cc¿s of blood which was auto-transfused back to the patient.The effusion stabilized and the case was abandoned.The patient will be reassessed for device closure at a later date.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Type of Device: 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: dan kitterman ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15094784
• MDR Text Key: 296498766
• Report Number: 2017233-2022-03154
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636495
• UDI-Public: 00733132636495
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASD32A
• Device Catalogue Number: ASD32A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/13/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 5 YR
• Patient Sex: Male
• Patient Weight: 15 KG