MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® DRYSEAL FLEX INTRODUCER SHEATH; TRANSCATHETER, SEPTAL OCCLUDER

Catalog Number DSF2033

Device Problem Migration (4003)

Patient Problem Foreign Body Embolism (4439)

Event Date 12/20/2023

Event Type  Injury  

Manufacturer Narrative

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 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale.The device was placed and locked at which time a bubble study was done.Bubbles were noted.The physician unlocked the leurs and attempted to retrieve the device.The right eyelet was pulled off the loop and the right disc was loaded, however, the center eyelet and the left disc would not load and kinking was noted.The physician was able to bring the device down to the groin sheath at which time the retrieval cord was removed.The physician tried to snare the device, however, it embolized to the pulmonary vein twice.The device was brought back down to the groin and a cut-down procedure was performed and the device was successfully removed.The procedure will be rescheduled for a future date.

Manufacturer Narrative

The gore® cardioform septal occluder instructions for states: adverse events associated with the use of the occluder may include but are not limited to: device embolization.

• Brand Name: GORE® DRYSEAL FLEX INTRODUCER SHEATH
• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18503719
• MDR Text Key: 332786973
• Report Number: 2017233-2024-04544
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132630066
• UDI-Public: 00733132630066
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DSF2033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2022
• 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; Hospitalization
• Patient Age: 44 YR
• Patient Sex: Female