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

Catalog Number ASD44E

Device Problem Migration (4003)

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

Event Date 07/21/2023

Event Type  Injury  

Event Description

It was reported to gore that on (b)(6) 2023, a 44 mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 18 - 23 mm and with an aortic rim of 0 - 2 mm.Following device implant, a push and pull test was performed and the device was found to be in a stable position.No issues were reported.On (b)(6) 2023, follow-up xray imaging reportedly showed the device had embolized into the aortic bulb.On (b)(6) 2023, the physician removed the device from the patient with a snare through the iliac artery and the access site was surgically closed.Using a balloon, the defect was found to measure approximately 26 mm and a 26 mm amplatzer¿ occluder was therefore selected and successfully implanted.The patient tolerated the procedure.

Manufacturer Narrative

Code "other": the device involved in this event was discarded at the facility after it had been removed from the patient.Therefore, an evaluation of the device cannot be performed.H6, 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.

Manufacturer Narrative

Emdr section h6: codes have been added/updated to reflect the extent of the investigation performed.This complaint was initiated based on information received from the field.Neither images enabling direct assessment of product performance nor the product itself, which remains implanted, were returned for evaluation.Therefore the cause of the reported device embolization could not be independently confirmed during the investigation.The available information reported does not reasonably suggest a potential malfunction has occurred.The reported device embolization represents a known complication or adverse event that can occur when using septal occluders and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen and patient-related risk factors.No allegation of device malfunction was indicated with respect to device performance.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.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.

Manufacturer Narrative

This complaint was initiated based on information received from the field.Neither images enabling direct assessment of product performance nor the product itself, which was discarded at the facility, were returned for evaluation.Therefore the cause of the reported device embolization could not be independently confirmed during the investigation.The available information reported does not reasonably suggest a potential malfunction has occurred.The reported device embolization represents a known complication or adverse event that can occur when using septal occluders and can arise as a result of a multitude of factors, including intraprocedural technical considerations, post-operative follow-up and treatment regimen and patient-related risk factors.No allegation of device malfunction was indicated with respect to device performance.Based on the incident description and the subsequent investigation, no further information was provided to gore, we are unable to determine the cause of this incident and assign a root cause.Codes provided in previous fu# 1 of mfr# (b)(4) remain unchanged.

• 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: 17584396
• MDR Text Key: 321537760
• Report Number: 2017233-2023-04216
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: ASD44E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/12/2023
• 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 Outcome(s): Required Intervention
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 65 KG