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

Model Number ASD37A

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

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

Event Date 03/03/2022

Event Type  Injury  

Event Description

It was reported to gore a 37mm gore® cardioform asd occluder was implanted on (b)(6) 2022 to treat an atrial septal defect.The physician reported on (b)(6) 2022 that the device had embolized to the left pulmonary artery.No further information was provided.The patient was taken to the catheterization lab for retrieval of the device; however, the attempt to retrieve the device was unsuccessful and the patient was taken to surgery.Update provided from the physician.The patient is doing fine after the surgery.

Manufacturer Narrative

As the date the embolization occurred is unknown at this time, the date gore aware (b)(6) 2022 is being used as the date of event.Requested patient weight, but is unknown.Imaging evaluation: from the fluoroscopy imaging provided the device appears to be in an unstable position on the atrial septum.However, without echocardiography, this cannot be confirmed.There does appear to be adequate tissue in between the posterior/inferior portions of the disc.The anterior/superior discs appear very flat indicating inadequate tissue in between the left and right discs.In the images and videos provided the device does not appear stable at the time of locking or releasing.The left and right discs are moving simultaneously as opposed to the proper motion of moving away from each other.This is indicative of an instable device.When going through the checklist for releasing gore cardioform asd occluder, it is noted in the checklist to make sure there is clear disc separation between the left and right disc in the lao/cra views.Without further imaging, it cannot be determined if the device had clear disc separation to leave the device in at the time of implant.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.

Manufacturer Narrative

H6: updated clinical code to 4439.Updated impact code to 4627 and 4624.Updated medical device problem code to 4003.

• 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: 13801891
• MDR Text Key: 287689548
• Report Number: 2017233-2022-02809
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• 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: 04/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/29/2021
• 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: 56 YR
• Patient Sex: Male