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

Catalog Number GSX0030A

Device Problem Mechanical Problem (1384)

Patient Problems Failure of Implant (1924); Thrombus (2101)

Event Date 03/16/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.Post procedure images were returned for review.The right atrial disc appears extended and unlocked per fluoroscopy.The right atrial disc appears bulbous and expanded per transesophageal echocardiography.A photo showing the removed device was also received.

Event Description

It was reported the physician implanted a 30mm gore® cardioform septal occluder to close an atrial septal defect with a static measurement of 11mm.At implant, the device was locked and there was no residual shunt.The day following the procedure, transthoracic echocardiography showed the device was unlocked and the right atrial disc had a bulbous appearance.The occluder was removed the same day in a transcatheter procedure, and a device from another manufacturer was implanted with no adverse effects.Inspection of the removed gore® cardioform septal occluder revealed a blood clot inside the right atrial disc.

Manufacturer Narrative

Device evaluation results: only the occluder was returned to gore for analysis.The investigation revealed that the size and shape of the occluder and lock loop were unremarkable.A blood clot was present in the right disc of the occluder.The investigation also revealed that the face hole was present.The cause of the device unlocking and the reported bulbous appearance of the right disc after it was implanted is unknown and cannot be determined from the evidence available.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7423757
• MDR Text Key: 105240051
• Report Number: 2017233-2018-00214
• Device Sequence Number: 1
• Product Code: MLV
• 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: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/07/2020
• Device Catalogue Number: GSX0030A
• Device Lot Number: 17751561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 71 YR
• Patient Weight: 68