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

Catalog Number GSX0025A

Device Problem Mechanical Problem (1384)

Patient Problem Failure of Implant (1924)

Event Date 07/18/2019

Event Type  Injury  

Manufacturer Narrative

A still image of the device was returned to gore for analysis.The imaging evaluation is in progress.

Event Description

It was reported the physician implanted a 25mm gore® cardioform septal occluder to close an iatrogenic atrial septal defect following a mitraclip procedure.One day following the procedure, imaging showed the device had unlocked.The occluder was removed with a snare in a transcatheter procedure and an amplatzer device was implanted with no reported adverse effects.

Manufacturer Narrative

One digital cine fluoroscopy still image was received for review.A gore® cardioform septal occluder is visualized implanted on what appears to be the atrial septum.The left and right atrial discs appear to be on their respective sides of the atrial septum, however, without echocardiography imaging this cannot be confirmed.The left atrial disc appears to be flat and well apposed.The right atrial disc appears to be larger than normal.The appearance of the right atrial disc is consistent with the right disc being expanded.The right atrial eyelet is unlocked from the locking loop.In the image, the right atrial eyelet can clearly be seen extended into the right atrium and the locking loop is capturing only the center eyelet.It is unclear from the imaging provided what may have caused this to occur.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8889539
• MDR Text Key: 154292916
• Report Number: 2017233-2019-00637
• 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: 08/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2020
• Device Catalogue Number: GSX0025A
• Device Lot Number: 18783726
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 72 YR