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

Model Number GSX0030A

Device Problems Break (1069); Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problem No Code Available (3191)

Event Date 10/28/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).Engineering evaluation of the returned device is in progress.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: access site complications requiring surgery, interventional procedure, transfusion, or prescription medication.

Event Description

It was reported to gore a 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale.Following locking, the device prolapsed into the left atrium.Upon retrieval the left disc did not unlock and the retrieval cord broke.The device was snared and brought back to the femoral vein; however, a femoral cut down was required to remove the device.The patient will be brought back at a future date to implant a gore® cardioform asd occluder.

Manufacturer Narrative

The engineering investigation revealed that approximately 11.5 cm of wire was protruding from the right occluder disc.The wire protrusion and damage may have been caused by the retrieval and snaring of the occluder; however, this cannot be confirmed from the evidence available.The delivery system was not returned to gore for analysis.The cause of the prolapse and broken retrieval cord is unknown and cannot be determined from the evidence available.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: access site complications requiring surgery, interventional procedure, transfusion, or prescription medication.W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• 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
• MDR Report Key: 10895833
• MDR Text Key: 217999957
• Report Number: 2017233-2020-01484
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/23/2022
• Device Model Number: GSX0030A
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Date Manufacturer Received: 10/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 74