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

Catalog Number ASD27B

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Arrhythmia (1721)

Event Date 10/16/2019

Event Type  Injury  

Manufacturer Narrative

Pma # p050006.

Event Description

It was reported, the physician implanted a 27mm gore® cardioform asd occluder to close a 15 mm atrial septal defect (asd).The patient had a small left atrium, so the smaller device was chosen.The patient went in and out of supraventricular tachycardia multiple times while the catheter was advanced but before device deployment.Adenosine was administered to bring the patient back to normal rhythm.Three attempts were made to get good apposition on the septum.Finally, the device looked well placed and was locked and released.Shortly after the patient left the cath lab, the device embolized to the right ventricle.Several attempts were made to snare or grab the device with a bioptome with no success, so the patient was taken to surgery to remove the device and repair the asd.The patient was doing well following the procedure.

Manufacturer Narrative

Images were received on (b)(6) 2019.A summary of the imaging review stated the following: it was reported that after several attempts a 27mm gore cardioform asd occluder was implanted successfully.Shortly after the patient left the lab the device embolized.The defect was measured to be slightly outside the ifu maximum treatment size for the 27mm device.The maximum treatment size is 15mm and the defect was balloon sized to 15.5 mm with echocardiography and 15.3mm with fluoroscopy.The retro aortic rim was completely deficient and the posterior rim was slightly deficient.The posterior rim was also thin and floppy.When determining what size device to select for closure with the gore cardioform asd occluder balloon sizing measurements, rim measurements and characteristics should be taken into consideration.With multiple deficient rims and a defect size at the maximum end of the treatment size, selecting the next size of device should be considered, if the size of the heart can accommodate it.In this defect a 32mm gore cardioform asd occluder should have been considered for implant due to the stop flow balloon size and the anatomy of the rims of the defect.Per the performing facility attempts were made to remove the embolized device and were unsuccessful.The patient was sent to surgery for device removal and asd repair.

• Brand Name: GORE® CARDIOFORM ASD OCCLUDER
• Type of Device: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9310732
• MDR Text Key: 166049343
• Report Number: 2017233-2019-01131
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Catalogue Number: ASD27B
• Device Lot Number: 18854742A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR
• Patient Weight: 11