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

Catalog Number GSXE0030

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Thrombosis/Thrombus (4440)

Event Date 07/07/2023

Event Type  Injury  

Event Description

It was reported to gore that on july 5, 2023, a 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale (pfo).The closure of the defect reportedly posed no problems.On (b)(6) 2023, the patient reportedly developed fever and a blood test revealed inflammatory markers without a bioburden.Additionally, the ultrasonic scan showed appositions on the left disc resembling thrombus formation.Reportedly, antibiotic treatment was started together with asprin and plavix medication as well as weight-adjusted enoxaparin.However, the treatment was reported to have been unsuccessful.Therefore, the physician explanted the device on (b)(6) 2023.It was reported that the explanted occluder device would be examined pathologically and microbiologically.

Manufacturer Narrative

H6, investigation findings, code 19: the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.H3, "other": gore will attempt to obtain investigation results of the explanted device.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.

Manufacturer Narrative

B3, date of incident: updated.B5, describe event or problem: updated.Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.H6, health effect - clinical code: code e0514 was retracted.Reportedly, the explanted device was discarded at the facility, therefore, it was not possible for gore to perform an explant evaluation.Additional information received indicated that the physician had the explanted device undergo microbiological and histopathological examinations at the university hospital's own facilities.Gore requested and received pre- and post explant examination results.Pre-explant, there reportedly was no microbiological evidence in six blood cultures, but crp values were elevated reaching 7.4 mg/dl, subsequently decreasing over the course under antibiotic medication.The physician also communicated that the mass agglomeration confirmed during transesophageal echocardiography imaging would not regress despite anticoagualant therapy, and it was therefore decided to explant the device.Intra-operative findings confirmed the agglomeration and the histopathological exam showed large quantities of granulocytes on the device but no bacteriae and no yeasts.According to the physician, an infectious etiology remains unlcear as there was no bacterial evidence.Concluding examination results reportedly state a significant local tissue reaction associated with granulocytosis and point to a suspected endocarditis.This complaint was initiated based on information received from the field.The available information does not suggest a device malfunction with respect to device performance.No further information was provided to gore for this patient.Based on the incident description and the subsequent investigation, we are unable to determine the cause of this incident and assign a root cause.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: endocarditis, interventional procedure.

Event Description

It was reported to gore that on (b)(6) 2023, a 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale (pfo).The closure of the defect reportedly posed no problems.On (b)(6) 2023, the patient was reportedly discharged but readmitted to hospital later the same day due to fever and a blood test revealed elevated inflammatory markers without a bioburden.C-reactive protein values had reached up to 7.4 mg/dl but reportedly decreased over the course.Additionally, the ultrasonic scan showed mass agglomeration on the left disc resembling thrombus formation.Reportedly, antibiotic treatment was started in combination with anticoagulant medication as well as weight-adjusted enoxaparin.However, follow-up transesophageal echocardiography (toe) imaging revealed no regression of the mass formation and it was therefore decided to explant the device on (b)(6) 2023.Microbiological findings showed no infectious agent in blood samples taken from the patient prior to the explant nor in the explanted device investigated by the hospital.During the explant however, mass formation on the device was confirmed with subsequent histopathological examination showing large quantities of granulocytes.Final results reported to the physician pointed to suspected endocarditis with an unclear infectious etiology and a significant local tissue reaction associated with granulocytosis.

• 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: 17630397
• MDR Text Key: 322025279
• Report Number: 2017233-2023-04236
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/18/2023
• 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: 59 YR
• Patient Sex: Female