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

Catalog Number GSXE0030

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

No patient specific details have been provided.Therefore, the patient initials reflect the w.L.Gore internal case number.The date of incident is unknown.Therefore, the publication date of the literature article is used as date of incident.Engineering evaluation could not be performed as the device was not returned.The gore® cardioform septal 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: device embolization.

Event Description

The literature article: "percutaneous closure of patent foramen ovale and secundum atrial septal defects with the gore® cardioform septal occluder: incidence and implications of device wire frame fracture" published by biagio castaldi et al.Was reviewed.The article was published september 23, 2020, in tech science press.The aims of the article was to assess the incidence and clinical significance of wire frame fractures (wff) after gore® cardioform septal occluder (gso) implantation in paediatric patients.77 patients underwent percutaneous transcatheter atrial septal defect (asd)/patent foramen ovale (pfo) closure with gso device between january 1, 2012 and december 31, 2018.In 7 patients the indication was pfo closure, in 70 patients asd closure.Mean patient age was 10.0 ± 3.9 years.In one patient, an embolized 30 mm gso device in pulmonary trunk was detected by a chest x-ray performed after 6 hours from the implantation.This patient underwent successful catheterization with removal of the embolized gso device and subsequent implantation of an competitor device.The patients was asymptomatic at last follow-up examination after 24 months.Wff was detected in a total of 22 (35.4%) gso devices, none of them resulted in any clinical sequelae/patient harm.The author concluded that gso devices are safe and effective for pfo and asd closure.Wff was not associated with clinical sequelae or device instability.

• 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: 12292617
• MDR Text Key: 265553611
• Report Number: 2017233-2021-02221
• 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: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2021
• 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: 07/31/2021
• 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): Required Intervention
• Patient Age: 10 YR
• Patient Weight: 38