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

Catalog Number GSXE0030

Device Problem Migration (4003)

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

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

Investigation findings: code c19 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.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 that a 30mm gore® cardioform septal occluder was selected to treat a patent foramen ovale.Having positioned the device at the intended location, it was reportedly not possible to neither lock nor release the device as it appeared stuck to the delivery catheter.In an attempt to liberate the device, the physician removed the retrieval cord, which also did not immediately solve the situation.However, the device eventually separated during the retraction movement of the catheter and the device embolized into the inferior vena cava.Using a snare, the physician removed the gore® cardioform septal occluder from the patient without issues.The patient tolerated the procedure.

Manufacturer Narrative

Additional manufacturer narrative: patient information a1 to a4: provided additional information.D.Suspected medical device: d2a/d2b: corrected product code.D8/d9: provided additional information.H6, investigation findings, code c19 was used in this supplemental medwatch report to reflect the engineering evaluation results.The device was returned to gore and an engineering evaluation was performed.The evaluation of the returned device showed the following: ¿ the locking mandrel, lock loop and retaining stiffener were unremarkable.¿ the retrieval cord and retrieval cord lock were not returned with the device.¿ the exostiffener exhibited damage and buckled during the load/deploy attempt.¿ the occluder appeared damaged from the snaring, but no clocking or other issues with size or shape were observed.The engineering evaluation could not confirm the failures associated with locking and release.Due to the return state of the device, the likely cause could not be determined from the evidence available.Section h6: codes have been added/updated to reflect the extent of the investigation performed.According to the gore® cardioform septal occluder instructions for use (ifu), adverse events associated with the use of the occluder may include, but are not limited to: device embolization.With the information reported to gore this investigation is considered complete, the cause of the complaint was unable to be determined.

• 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: 16501164
• MDR Text Key: 310858064
• Report Number: 2017233-2023-03784
• 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,Followup
• Report Date: 10/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: GSXE0030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/15/2022
• 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
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 60 KG