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

Catalog Number GSX0025A

Device Problem Mechanical Problem (1384)

Patient Problem No Information (3190)

Event Date 07/14/2020

Event Type  Injury  

Manufacturer Narrative

Citation: sahil khera, richard ro, barry love, parasuram krishnamoorthy, gila perk, gilbert h.L.Tang, samin sharma, annapoorna kini & stamatios lerakis (2020) extreme right atrial disc expansion of septal occluder post iatrogenic atrial septal defect closure, structural heart, doi: 10.1080/24748706.2020.1790704.The gore® cardioform septal occluder instructions for use note that the device is indicated for the percutaneous, transcatheter closure of ostium secundum atrial septal defects (asds).The authors note the device was used to close an iatrogenic asd, which is considered off-label use for this device.Additionally, the gore® cardioform septal occluder instructions for use note intervention for device failure or ineffectiveness as a potential device or procedure-related adverse event.

Event Description

This information was received through literature article "extreme right atrial disc expansion of septal occluder post iatrogenic atrial septal defect closure" posted online 14 july 2020 in structural heart.The article reports a (b)(6) male underwent successful mitracip transcatheter mitral valve repair.The residual atrial septal defect (asd) was measured at 12mm x 12mm by doppler and the decision was made to close the asd due to the large left to right shunt.Implantation of a 25mm gore® cardioform septal occluer was uneventful, with transesophageal echocardiography (tee) demonstrating good device apposition and normal device appearance.Tee performed the following morning demonstrated a circular echodensity at the right atrial side of the interatrial septum.With further evaluation via fluoroscopy, extreme expansion of the right atrial disc with displacement of the locking pin was seen.The device was removed with a gooseneck snare and bioptome.An alternative nitinol mesh-based occluder was implanted with unremarkable appearance on follow-up imaging.

Event Description

2020-01109-1.

Manufacturer Narrative

This report was inadvertently duplicated and will be retracted.The original manufacturer report number is 2017233-2019-00637.

• Brand Name: GORE CARDIOFORM SEPTAL 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: 10391279
• MDR Text Key: 202424781
• Report Number: 2017233-2020-01109
• Device Sequence Number: 1
• Product Code: MLV
• 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,litera
• Type of Report: Initial,Followup
• Report Date: 08/13/2020

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: GSX0025A
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/21/2020
• Initial Date FDA Received: 08/11/2020
• Supplement Dates Manufacturer Received: 07/21/2020
• Supplement Dates FDA Received: 08/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 72 YR