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

Catalog Number GSXE0025

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 01/23/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).The review of the manufacturing records verified that this lot met all pre-release specifications.

Event Description

It was reported a 25mm gore® cardioform septal occluder was selected to close an atrial septal defect measuring 9mm by transesophageal echocardiogram (tee) with a septal length 20-23mm and a deficient aortic rim.The device was implanted without difficulty, but a small residual shunt was noted.The physician decided to leave the device in place and re-evaluate the following day.Tee was performed the following day and a significant shunt was noted.The patient was taken to surgery where the device was removed and the defect surgically repaired.The patient was doing well following the procedure.

• 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: kathy titus ; 9285263030
• MDR Report Key: 5436950
• MDR Text Key: 38225654
• Report Number: 2017233-2016-00122
• Device Sequence Number: 1
• Product Code: MLV
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/02/2017
• Device Catalogue Number: GSXE0025
• Device Lot Number: 13623295
• 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: 03/19/2015
• 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; Required Intervention
• Patient Age: 3 YR
• Patient Weight: 11