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

Catalog Number ASD48E

Device Problem Migration (4003)

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

Event Date 03/16/2023

Event Type  Injury  

Manufacturer Narrative

Code c19 - the review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.The explanted gore® cardioform asd occluder was discarded at the facility.Therefore, a device investigation could not be performed.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 on (b)(6) 2023 a 48 mm gore® cardioform asd occluder was selected to treat an atrial septal defect without a retro-aortic rim and measuring about 31 mm having used stop flow balloon sizing.Both angiography imaging and transesophageal echocardiography confirmed the device was well positioned.After an hour it was observed that the device had embolized into the right atrium and pulmonary artery.The physician subsequently removed the device percutaneously without issues using a 24 french sheath.The patient tolerated the procedure.

Manufacturer Narrative

Additional manufacturer narrative: emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.Imaging evaluation summary: an electronic file containing digital cine fluoroscopy images was returned to gore and an imaging evaluation was performed.The findings are described below: it was reported that a physician used a 48mm gore cardioform asd occluder to close an atrial septal defect.1 hour post op it was noted the device had embolized.From the limited fluoroscopy imaging provided the device appears to have been successfully implanted.The left and right discs appear to have good splay.This appearance is consistent with the left and right discs being on the appropriated sides of the atrial septum, however, without echocardiography this could not be confirmed.From the imaging provided it is difficult to ascertain the cause for the device embolization.Per the performing physician the device was percutaneously removed successfully.According to the gore® cardioform asd 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 ASD 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: 16712948
• MDR Text Key: 313030387
• Report Number: 2017233-2023-03850
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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: 10/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD48E
• Was Device Available for Evaluation?: No
• 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: 03/16/2022
• 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: 43 YR
• Patient Sex: Female
• Patient Weight: 53 KG