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

Catalog Number GSXE0025

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Pericardial Effusion (3271)

Event Date 01/06/2023

Event Type  Injury  

Manufacturer Narrative

"other" code: the device remains implanted.Code c19 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.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 to gore that a 25mm gore® cardioform septal occluder was selected to treat a patent foramen ovale (pfo) balloon sized to 10mm.Performing the procedure under fluoroscopy and intra-echography (ice), the defect was crossed without issues.It was reported that deployment of the left disk was challenging due to confined spatial conditions, thus the device was retracted back into the delivery system for repositioning.Subsequently, the left disk was deployed and positioned at the septum, followed by deployment of the right disk that also formed.Appearing adequately positioned, the device was locked and released.However, ice watch reportedly revealed a small effusion and it was therefore decided to monitor the effusion with a transthoracic echocardiogram in 10 minute and blood pressure in 5 minute intervals.Additionally, 80mg of protamines were administered.Both blood pressure and heart rate then dropped and a pericardial drain was performed, which resulted in the successful drainage of the effusion.Platelets were given, all anticoagulation was stopped and the patient was transferred to the cardiac care unit (ccu).Removal of the drain was scheduled in a couple of hours with the patient remaining at the ccu for further observation.

Manufacturer Narrative

H6, health effect - impact code: added code f12 h6,type of investigation: added codes b11, b20 h6, component code: added codes g04088 membrane, g04027 chassis/frame h6, investigation conclusions: added code d12 according to the gore® cardioform septal occluder instructions for use (ifu), adverse events associated with the use of the occluder may include, but are not limited to: significant pericardial effusion requiring drainage and access site complications requiring interventional surgical procedure.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.H6, investigation conclusions: replaced code d16 with code d15.

• Brand Name: GORE® CARDIOFORM SEPTAL 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: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16287488
• MDR Text Key: 308707453
• Report Number: 2017233-2023-03683
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GSXE0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2022
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male
• Patient Weight: 74 KG