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

Catalog Number ASD37E

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)

Patient Problems Obstruction/Occlusion (2422); Foreign Body Embolism (4439)

Event Date 03/23/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifiers-initials, dob/age, weight, requested but not available.The gore case number 00008317 is being used as patient identifier.Imaging evaluation: the device was positioned well and it appeared to be in a stable but not locked position.However, without additional imaging this cannot be confirmed.It was reported that after locking and releasing the device, the physician noted that the locking loop was still constrained in the control catheter.This is typical in a delayed lock release.Prior to releasing the device, rocking the handle back and forth can help release the locking loop from the control catheter.Additionally, loosening the delivery catheter at the luer lock and advancing it over the grey control catheter to the right atrial eyelet and slightly pushing the device can help release the locking loop from the control catheter.The retrieval cord was released prior to trying these measures causing the device to become unstable when advancing the delivery catheter over the grey control catheter.They device became dislodged and ended up in the pulmonary artery.A loop snare was then advanced to retrieve the device.The device was retrieved and per the performing facility, the patient was sent for surgical repair of the defect.The gore® cardioform asd occluder instructions for use states: potential clinical and device adverse events associated with the use of the occluder may include, but are not limited to: device embolization.

Event Description

It was reported to gore a 37mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 21mm by balloon sizing with deficient aortic rim.The device was aligned nicely on the septum and no residual shunt was detected.The device was locked and released.After removing the retrieval cord the physician noticed that the locking loop was still inside the catheter, therefore, he opened the luer lock and advanced the trans-septal sheath to the left and pulled on the handle.During this maneuver, the device embolized into the pulmonary artery and had to be snared.The patient was sent for surgical closure of the defect.

Manufacturer Narrative

H6: added type of investigation codes 4112 and 4117.Added conclusion code 22.

Manufacturer Narrative

B3: added additional information.H6: added type of investigation code 4111.Added investigation findings code 3207.Added investigation conclusion code 50.Patient identifiers, initials, dob/age, and weight were requested but not provided.H6: health effect clinical code changed to 4439.Medical device problem code changed to 4003.

Event Description

It was reported to gore a 37mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 21mm by balloon sizing with deficient aortic rim.The device was aligned nicely on the septum and no residual shunt was detected.The device was locked and released.After removing the retrieval cord the physician noticed that the locking loop was still inside the catheter, therefore, he opened the luer lock and advanced the trans-septal sheath to the left and pulled on the handle.During this maneuver, the device embolized into the pulmonary artery and had to be snared.The patient was sent for surgical closure of the defect.Received additional information that the physician indicated the patients anatomy was the most likely cause of the device embolizing.

• 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: kathy titus ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13968491
• MDR Text Key: 288315628
• Report Number: 2017233-2022-02836
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/05/2023
• Device Catalogue Number: ASD37E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2022
• Initial Date FDA Received: 03/31/2022
• Supplement Dates Manufacturer Received: 03/23/2022; 03/23/2022
• Supplement Dates FDA Received: 04/14/2022; 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/05/2020
• 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): Hospitalization; Required Intervention
• Patient Sex: Female