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

Catalog Number GSX0025A

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Bacterial Infection (1735); Embolism (1829); Fever (1858)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing and sterilization records verified the lot was processed normally and all pre-release specifications were met.Case images and images of the explanted device (device not returned) were received by gore for analysis.The imaging and engineering evaluations are in progress.

Event Description

It was reported the physician implanted a 25mm gore® cardioform septal occluder to close an atrial septal defect on (b)(6) 2019.The patient presented recently with an acute onset fever, malaise and back pain.Multiple blood cultures were positive with s aureus.A brain mri demonstrated multi focal septic emboli in the cerebrum and cerebellum.The patient's neurological exam was normal.On (b)(6) 2019, transesophageal echocardiology showed a vegetation on the left atrial surface of the occluder.On (b)(6) 2019, the device was explanted the defect was surgically closed.The patient did well following the surgery and was discharged after seven days with no long term neurologic concerns.

Manufacturer Narrative

Electronic files containing digital echocardiography images were received for review.The imaging shows a gore® caridoform septal occluder deployed on the atrial septum.The left and right discs appear to be on their appropriate side of the atrial septum and in good position.An echogenic mass that is consistent with a vegetation is seen on the surface of the left atrial disc of the device.Images of the explanted device were provided for review; however, an engineering analysis cannot be completed due to the state of the device in the returned images.The cause of the symptoms experienced by the patient and reported vegetation on the left atrial disc surface is unknown and cannot be determined from the returned images.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8888078
• MDR Text Key: 154136469
• Report Number: 2017233-2019-00624
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631025
• UDI-Public: 00733132631025
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/11/2020
• Device Catalogue Number: GSX0025A
• Device Lot Number: 18347655
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 6 YR