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 Endocarditis (1834); Thrombosis/Thrombus (4440)

Event Date 04/15/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all prerelease specifications.Device evaluated by mfr: engineering evaluation could not be performed as the device remains implanted.(b)(4).

Event Description

It was reported to gore that a 30mm gore¿ cardioform septal occluder was intended to be used to treat a patient with patent foramen ovale.The implantation procedure on (b)(6) 2021 was fine.The patient received heparin during the procedure and antibiotics (cefasolin 2gr) was administered.One day post-implant in the morning of (b)(6), the echocardiogram results were fine and the device looked ok.In the evening it was reported that the patient had a temperature of 37.8 degrees and received antibiotics (cefixsoral 400 x 2).On (b)(6), the patient suffered from fever at 39 degrees and shivers.On (b)(6), echocardiogram showed a thrombotic mass on the right side on the disc.The physicians started antibiotic therapy for endocarditis (tazocin + daptomycin).In the meantime aspirin and plavix have been suspended, and anticoagulation was started.The fever was gone on (b)(6), the following values where documented: pcr max 7, procalcutonin 0, white blood cells peak 12,500 then 8,500 (decreasing), no symptoms, no organ recall.The blood cultures results are negative.It was reported that the patient is asymptomatic and fever free since (b)(6) 2021.Fluroroscopy showed that the occluder device is perfect in site on (b)(6) 2021.Echocardiogram showed vegetation/mass on both left and right.Values pcr 1.3, and white blobs 10,700 were documented.It is not yet decided if the device will be removed surgically.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 11841508
• MDR Text Key: 251195950
• Report Number: 2017233-2021-02015
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2023
• Device Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2021
• Date Device Manufactured: 11/03/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 29 YR