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

Device Problem Migration (4003)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  Injury  

Manufacturer Narrative

H3, "other" code: the device was discarded at the facility.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.

Event Description

It was reported to gore a gore® cardioform septal occluder was selected to treat a patent foramen ovale (pfo).Having deployed the left disc in the left atrium without issues, the physician reportedly started to deploy the right disc in the right atrium without realizing that a portion of the right disc was also deployed in the left atrium.Due to the now unequal deployment forming a somewhat elongated shape, it was not possible to lock the device and it prolapsed into the left atrium.It was therefore decided to remove the device.To do so, the physician opened the retrieval cord lock but, reportedly in error, pulled the handle until the entire cord was removed from the handle.As the device now no longer was connected to the retrieval cord, it embolized into the aorta.Subsequently, the device was caught with a snare and removed from the patient.To proceed with the procedure, an amplatzer® occluder was selected and the pfo was closed successfully.Reportedly, the patient was doing well.

• 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
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: thomas giebing ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18882876
• MDR Text Key: 337403201
• Report Number: 2017233-2024-04701
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male