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

Catalog Number GSX0030A

Device Problems Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)

Patient Problem Foreign Body Embolism (4439)

Event Date 11/10/2023

Event Type  malfunction  

Manufacturer Narrative

A fluoroscopic image was provided for review.The image revealed a gore cardioform septal occluder successfully deployed over the patent foramen ovale.The position and the appearance of the occluder was unremarkable.A pulmonary artery angiogram confirmed that the radiopaque tip of the delivery system was lodged in the upper pulmonary artery.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 the physician selected a gore® cardioform septal occluder to treat a patent foramen ovale (pfo).The physician was unable to cross the small tunnel pfo with an 11f venous sheath.The physician thought that the 11f sheath was possibly kinked, so pulled it out over the delivery sheath and guidewire, then tried to remove the delivery device "sheathless".This was not possible and ultimately the delivery sheath was pulled out, at which point, it was noted the delivery sheath tip was missing.Originally, the tip was still on the guidewire and the sheath was upsized to a 16f sheath in an attempt to retrieve it.The piece could not be retrieved and it slipped off the wire and embolized into the terminal portion of the left upper pulmonary artery (as visualized on a pa gram).An interventional radiologist physician looked at the imaging and noted he had nothing to retrieve the embolized delivery catheter tip with in that position and suggested leaving it where it was as it was small.The tip was left in the patient.The pfo tunnel was ballooned and was closed with another device.The patient was doing well following the procedure.

Manufacturer Narrative

The device was discarded by the facility and no images of the device after removal were provided.An engineering analysis was performed based on the event description.During the attempts to cross the small tunnel pfo, the tip of the delivery catheter may have kinked with the 11f sheath.If the tip of the delivery catheter was kinked within or distal to the pfo, this would increase the possibility of entanglement with the anatomy of the pfo (e.G., flaps of the septum primum or septum secundum) during removal attempts.After the 11f sheath was removed, there was difficulty removing the delivery catheter.Since the sheath was no longer covering the catheter, this could mean that the tip of the delivery catheter was held in place by the anatomy of the pfo while the delivery system was pulled.If sufficient tension was applied to the delivery catheter while the tip of the delivery catheter was pinned, the tip of the delivery catheter may have separated at the guidewire port where the cross-sectional area is less than the body of the delivery catheter.The physician¿s observations of the difficulty crossing the defect, kinked accessory sheath and device fragment remaining in the patient are confirmed by the description and fluoroscopic image provided.The cause of the difficulty in removing the delivery catheter from the anatomy and the separation of the tip of the delivery catheter cannot be definitively determined with the evidence provided.

Manufacturer Narrative

Lot number received and sections d4 and h4 updated.A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.

• 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18220405
• MDR Text Key: 329349054
• Report Number: 2017233-2023-04433
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132631032
• UDI-Public: 00733132631032
• 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,Followup
• Report Date: 01/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GSX0030A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/19/2023
• 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 Sex: Male