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

Model Number ASD44A

Device Problems Inadequacy of Device Shape and/or Size (1583); Separation Failure (2547)

Patient Problem Insufficient Information (4580)

Event Date 03/22/2022

Event Type  malfunction  

Event Description

The patient was in cardiac cath lab for asd (atrial septal defect) closure procedure with right heart catheterization procedure with tee.The interventionalist used a 34mm amplatzer sizing balloon over an amplatzer extra stiff wire to size the defect, with a diameter of 29mm by fluoroscopy and tee.The interventionalist attempted deployment of a gore cardioform asd 44mm and 48mm devices.Neither would sit well (they were both parallel to the septum, despite the best wire position we could obtain) and could not be deployed safely across atrial septum despite manipulation.Another interventionalist kindly came to assist original interventionalist and could also not deploy the 44m device, nor the 48mm, in adequate position (both discs would deploy partially in the left atrium).The team switched to a goodale lubin, magic torque and amplatzer super stiff wires to get better left pulmonary vein position, without an improvement in device delivery direction.It was difficult to withdraw the 44mm device in its delivery sheath; it was almost completely withdrawn in the delivery sheath, then pulled to ivc, and removed from the long femoral vein sheath.It was intact when it came out of the body but deformed (may have warped when it was deployed/recaptured several times).The team therefore switched to a hausdorf cook sheath and a 32mm amplatzer asd closure device.It was deployed smoothly in one attempt, without complications.It sat well by fluoroscopy and tee.Per quality chair review, he spoke with interventional dr.About the procedure.The interventionalist noted that the 44 mm asd closure device did not fit in a favorable way.The interventionalist attempted to manipulate the device to fit more favorably, then ultimately attempted to recapture and remove the device without deploying it.Either due to the extensive manipulation of the device, or possibly due to a device malfunction, it was difficult to recapture the device, which was ultimately removed with a distorted shape.Manufacturer response for transcatheter septal occluder, gore cardioform asd occluder (per site reporter) unknown.

• Brand Name: GORE CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): W. L. GORE ASSOCIATES, INC.; 1505 north fourth st.; flagstaff AZ 86004
• MDR Report Key: 15334711
• MDR Text Key: 299064456
• Report Number: 15334711
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ASD44A
• Device Catalogue Number: ASD44A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/24/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/01/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 14965 DA
• Patient Sex: Male
• Patient Weight: 229 KG
• Patient Race: White