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

Catalog Number GSXE0030

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).

Event Description

It was reported the physician selected a 30mm gore® cardioform septal occluder to close a septal defect in a patient who presented with hypoxemia.The occluder was successfully placed and locked; however, the retrieval cord broke while releasing the device.The physician was unable to remove the remaining cord from the device and opted to cut it with a proglide system in the ilio-femoral vein.A portion of the cord remains attached to the device and extends along the inferior vena cava.The occluder remains well positioned and the patient was doing well following the procedure.

Manufacturer Narrative

The occluder remains implanted and cannot be evaluated; however, the delivery system was returned to gore for analysis.The investigation revealed that the retrieval cord was broken approximately 110cm from the retrieval cord lock and also approximately 57cm from the free end.The tip of the delivery catheter exhibited slight deformation.All other delivery system components, including the sliding and locking mechanisms, were unremarkable.The cause of the broken retrieval cord 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: 7465273
• MDR Text Key: 106975388
• Report Number: 2017233-2018-00239
• 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: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/21/2019
• Device Catalogue Number: GSXE0030
• Device Lot Number: 17474212
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2018
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 99