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

Model Number ASD37A

Device Problems Expulsion (2933); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Obstruction/Occlusion (2422)

Event Date 01/09/2021

Event Type  Injury  

Manufacturer Narrative

The gore® cardioform asd occluder instructions for use list device embolization as a potential clinical and device adverse event.

Event Description

It was reported the physician implanted a 37mm gore® cardioform asd occluder to treat an atrial septal defect stop-flow balloon sized to 20-22mm.No major rim deficiencies were noted.The day following the implant, echocardiography showed the device had embolized to the right pulmonary artery.The device was removed with a snare and a 28mm amplatzer septal occluder was implanted with no adverse effects.

Manufacturer Narrative

Case imaging was reviewed.During the assessment of the defect, the performing facility acquired a balloon stop flow size of 20mm x 21mm by echocardiography.The sizing balloon did not have a clear waste on fluoroscopy but in the echocardiography images it did appear that stop flow was achieved.The retro aortic rim was deficient and the posterior rim was present but appeared very thin.All other rims appeared sufficient in the images provided.The device was implanted and appeared to successfully capture rim tissue all around.The left and right discs appear to be on their respective sides of the atrial septum.On fluoroscopy imaging, the device appears to be in a typical position, the right and left discs appear separated and on their respective sides of the atrial septum.On echocardiography there does appear to be a small residual shunt posterior to the device; however, it is difficult to determine if a portion of the defect is not covered by the device or if this is flow out of one of the perforations in the right atrial disc.Per the performing facility, the following day the device embolized and was successfully removed from the right pulmonary artery.The defect was then reassessed.On the echocardiography images provided, the retro aortic rim appears the same.However, during assessment of the posterior rim, the rim appears more deficient then previously imaged.A static measurement of the defect size was approximately 27mm and a balloon stop flow measurement of 26mm x 24mm was acquired on echocardiography.On fluoroscopy, during balloon stop flow, a waist is clearly visualized and the measurement acquired by the performing facility was approximately 24mm x 25mm.Per the performing facility an amplatzer device was successfully implanted.Comparing the imaging provided from the initial assessment of the defect to the reassessment of the defect, it appears that the gore® cardioform asd occluder was undersized.During the initial assessment of the defect it would appear the 37mm gore® cardioform asd occcluder was appropriate.With a defect treatment size of 18mm ¿ 25mm and the defect stop flow balloon size of approximately 20mm x 21mm.However, on the reassessment of the defect it appears to be larger.With the multiple deficient rims and the largest balloon stop flow size measuring 26mm.For a defect of this size it is recommended to use the 44mm gore® cardioform asd occluder.The defect treatment size of this device is 23mm ¿ 30mm.The gore® cardioform asd occcluder instructions for use state: "the septal tissue margins surrounding the defect must be of sufficient size and integrity to prevent disc prolapse through the defect and gore® cardioform asd occluder embolization.".

• 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
• MDR Report Key: 11224388
• MDR Text Key: 229526274
• Report Number: 2017233-2021-01621
• Device Sequence Number: 1
• Product Code: MLV
• UDI-Device Identifier: 00733132636501
• UDI-Public: 00733132636501
• Combination Product (y/n): N
• PMA/PMN Number: P050006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2022
• Device Model Number: ASD37A
• Device Catalogue Number: ASD37A
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 16 YR
• Patient Weight: 51