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

Catalog Number ASD37E

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

Event Description

It was reported to gore that on (b)(6) 2022, a 37mm gore® cardioform asd occluder was selected to treat an atrial septal defect measuring 15mm on balloon sizing, questionable residual flow on trans-oesophageal echocardiogram (toe), but waist on fluoroscopy.On initial deployment the device looked very flat.The device was redeployed and initially looked good but then it was seen on toe that it had come through into the right atrium.The device was taken out and flushed.There was discussion regarding reattempting with this device and it was felt that one last attempt would be made.The device redeployed and locked, however, when the device was locked it rotated, but appeared to be in a good position on toe, and although multiple fluoroscopy angles taken to see separation it was difficult.The physician was happy to release the device.When the device was fully released there was a very small inferior residual leak.The device was left in place.The patient was scanned around lunch time and the device was still in place.The patient had an echocardiogram the next morning and the device was there.A chest x-ray was done prior to patient the being discharged and the device was noted to be in the left pulmonary artery.The patient was offered trans-catheter removal or surgical removal.It was reported the device was successfully removed surgically on (b)(6) 2022.The patient was extubated and sitting out of bed on (b)(6) 2022.Further update was provided that the patient was discharged to home and is doing well.

Manufacturer Narrative

H10/11: a request for additional information as to the cause of the device embolizing was made, however, no further information was reported to gore.The gore® cardioform asd occluder instructions for use states: adverse events associated with the use of the occluder may include but are not limited to: device embolization h6: health effect - clinical code changed to 4439.Medical device problem code - removed 2993 and added 4003, 1583.Type of investigations codes - 4114 changed to 4117, added 4111.Investigation findings code 3233 updated to 213, 3207.Investigation conclusions codes updated code 11 to 4315, 22.

• 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: 14189912
• MDR Text Key: 290539568
• Report Number: 2017233-2022-02869
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 05/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/23/2024
• Device Catalogue Number: ASD37E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/24/2021
• 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; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Female
• Patient Weight: 69 KG