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

Catalog Number GSX0030A

Device Problems Malposition of Device (2616); Human-Device Interface Problem (2949)

Patient Problems Bradycardia (1751); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 08/10/2017

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records verified the lot was processed normally and all pre-release specifications were met.(b)(4).

Event Description

It was reported the physician selected a 30mm gore cardioform septal occluder to close a long tunnel patent foramen ovale.During the beginning of left disc deployment, echocardiography showed the disc forming in the tunnel.The physician pushed the device forward with the left disc still partially formed.Pressure between the disc and septal tissue caused the delivery catheter to spring forward when it cleared the tunnel.The patient mentioned he felt something happen; the doctor removed the device and assessed the patient for pericardial effusion, but nothing was found.The device was flushed, advanced, and deployed again with good result.At this time, a pericardial effusion was noted and the patient became severely bradycardic.The physician locked the device and removed the delivery system, medications were administered, and an emergency pericardiocentesis was performed.Following pericardiocentesis, the patient stabilized.There were no additional complications reported following the pericardiocentesis.

• Brand Name: GORE® CARDIOFORM SEPTAL OCCLUDER
• Type of Device: OCCLUDER, TRANSCATHETER SEPTAL
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): KENDRICK PEAK MPD B/P; 4250 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marci stewart ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6819267
• MDR Text Key: 83606349
• Report Number: 2017233-2017-00430
• Device Sequence Number: 1
• Product Code: MLV
• 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
• Report Date: 08/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/22/2019
• Device Catalogue Number: GSX0030A
• Device Lot Number: 16025165
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2017
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 113