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

Model Number ASD32A

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body Embolism (4439)

Event Date 06/16/2023

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform asd occluder instructions for use list device embolization as a potential device and procedure-related adverse event.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 implanted a 32mm gore® cardioform asd occluder to treat an atrial septal defect balloon sized to 18mm with a deficient posterior inferior rim.Approximately 12 hours post implant, the device embolized.The patient was brought back to the cath lab to retrieve the device; however, the device appeared to be entrapped within the tricuspid valve and the patient was sent for surgical device removal and defect closure.The patient was doing well following surgery.

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.One post procedural fluoroscopic image was provided for evaluation.The image shows the device is in a locked and released position.It appears there is a left atrial petal prolapsed into the fossa ovalis.Without additional imaging, this cannot be confirmed.There is clear disc separation around the posterior/inferior portion of the device.The suspected petal prolapse indicates that the device might not be stable, but without additional imaging, this cannot be confirmed.Pictures of the explanted device were provided for evaluation.The images show that on removal of the occluder, all petals of the occluder are fully formed and expanded and the lock loop is intact.

• 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: marci stewart ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17286982
• MDR Text Key: 318694907
• Report Number: 2017233-2023-04094
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636495
• UDI-Public: 00733132636495
• 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: 07/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASD32A
• Device Catalogue Number: ASD32A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/26/2023
• 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: 5 YR
• Patient Sex: Female
• Patient Weight: 25 KG