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

Catalog Number GSXE0025

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

Patient Problems Pulmonary Embolism (1498); Ischemia (1942); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)

Event Date 04/05/2021

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all prerelease specifications.Engineering evaluation could not be performed as the device was not returned.Adverse events associated with the use of the occluder may include, but are not limited to: thrombosis or thromboembolic event resulting in clinical sequelae.

Event Description

It was reported to gore a 25mm gore¿ cardioform septal occluder was selected to treat a patient with patent foramen ovale (pfo).The pfo closure procedure on the (b)(6) 2021 went on without complications, the patient received non-fractionated heparin (hnf) and then duoplavin without interruption.In the following days, the patient complained of paroxysmal headaches.Day 14 after implantation, (b)(6), the device was reported to be in good position.The patient described a limp on exertion of his right leg.On (b)(6), it was reported that the patient suffered ischemia of the right lower limb, popliteal embolism, and bilateral pulmonary embolism.The platelet count was 36g/l.The patient was hospitalized for vascular surgery.The doppler showed a complete thrombosis of the popliteal artery.And due to the thrombocytopenia, the surgery wasnt realized.A 28mm thrombus was discovered in the left atrium against the left disc of the gore¿ cardioform septal occluder device.On (b)(6), it was reported that the patient suffered from floating thrombosis at the origin of the right internal carotid artery with occlusion to the t carotid.No stroke was reported.On (b)(6), trans oesophageal echocardiogram showed thrombus progressed on the left and the right disc of the gore¿ cardioform septal occluder device (29x13mm on the left, 14x10mm on the right).The patient underwent intracardiac thrombectomy and gore¿ cardioform septal occluder device was explanted.It was also reported that the patient had heparin-induced thrombocytopenia with presence of anti-pf4 antibodies.The patient was treated with argatroban and immunoglobulin.

• 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: 11824134
• MDR Text Key: 250612335
• Report Number: 2017233-2021-02004
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/07/2023
• Device Catalogue Number: GSXE0025
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2021
• Date Device Manufactured: 10/07/2020
• 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: 48 YR