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

Catalog Number ASD48E

Device Problems Break (1069); Entrapment of Device (1212); Fracture (1260); Retraction Problem (1536); Malposition of Device (2616); Device Handling Problem (3265)

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

Event Date 07/11/2023

Event Type  Injury  

Event Description

It was reported to gore that a 48 mm gore® cardioform asd occluder was selected to treat an atrial septal defect with a challenging anatomy.Reportedly, the physician could not get the device to sit properly on the septum during the first four positioning attempts.Striving to better accomodate the device to the anatomy of the septum and the size of the defect, the physician reportedly deployed the device outside of the patient, bent the catheter close to the discs and retracted it back into the catheter.However, when trying to open the device inside the patient's heart it flipped, and a very sharp metal jumped out of the sheath together with the whole occluder device.Reportedly, the physician managed to remove the device from the heart but could not retract it back into the sheath as during the retraction attempt, the device became stuck in the vein.A small incision was made by a surgeon to entirely remove the stuck device portion that was still attached to the delivery system.No further clinical sequelae for the patient were reported.Defect closure during open surgery is currently being considered.

Manufacturer Narrative

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

B1: updated section to include product problem (e.G., defects/malfunctions).

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all prerelease specifications.An electronic file containing a digital cine fluoroscopy images was shared with gore for evaluation.The evaluation summary states that a gore cardioform asd occluder is visualized.In the image, the mandrel appears to be free from the control catheter and is positioned perpendicular to the long axis of the delivery catheter.Additionally, the mandrel is bent 90 degrees superiorly from its normal position.Furthermore a picture of the device was shared with gore for evaluation.The evaluation summary states that a gore cardioform asd occluder is visualized.The image depicts a device that has been removed from the patient.The mandrel is separated from the control catheter, bent 90 degrees from its normal presentation and extending through the side of the fabric of the device immediately distal to the left eyelet.The device remains attached to the delivery catheter via the retrieval cord.Product evaluation summary - the gore® cardioform asd occluder asd48e/24948722 was returned to gore and an engineering evaluation was performed.The evaluation of the device showed the following: the lock release shuttle was in the fully unlocked position and the control shuttle was in the deployed position.The occluder was attached to the delivery system by the retrieval cord.The size and disc shape of the occluder returned to normal with manual manipulation.The sliding and locking mechanisms functioned without resistance or difficulty.The lock loop, and retrieval cord were found to be broken.The distal end of the locking mandrel was found to be broken and initially located in the left atrial eyelet of the occluder.The observation of ¿a very sharp metal jumped out of the sheath together¿ as reported, is most likely referring to the broken locking mandrel component, which was confirmed during the evaluation.The lock loop and retrieval cord were found to be broken in the evaluation.It is likely the reported difficulty withdrawing the device into the sheath, most likely due to the broken mandrel, may have contributed to the damage to the lock loop and retrieval cord.The increased manipulation from the physician¿s actions most likely contributed to the fatigue of the locking mandrel, however the exact root cause of the locking mandrel breaking could not be determined.The reported adverse event can occur when using septal occluders and can arise as a result of a multitude of factors, including but not limited to, intraprocedural technical considerations.Based on the incident description and the subsequent investigation, no further information was provided to gore and we are unable to determine the exact cause of this incident and assign a root cause.Adverse events associated with the use of the septal occluders may include, but are not limited to: device fracture resulting in clinical sequelae or surgical intervention.Also, the section precautions in the gore® cardioform asd occluder instructions for use caution to inspect the product prior to use in the patient and not to use if the product has been damaged.

• 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: 17442271
• MDR Text Key: 320214470
• Report Number: 2017233-2023-04165
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASD48E
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2022
• 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: 12 YR
• Patient Sex: Female
• Patient Weight: 48 KG