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

Catalog Number GSX0030A

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Embolism (1829)

Event Date 05/23/2016

Event Type  Injury  

Event Description

It was reported a 30mm gore® cardioform septal occluder was chosen and implanted on (b)(6) 2016 to close an atrial septal defect with a deficient retro aortic rim and a static measurement of 12-14mm and stop flow measurement of 17-20mm.All other rims were adequate.The device and patient were stable following completion of the procedure and the patient was discharged the following day.Follow up echocardiogram on (b)(6) 2016 showed the device had embolized to the pulmonary artery.The patient was asymptomatic.Surgical removal of the device and closure of the defect took place on (b)(6) 2016.It was reported the patient is stable and recovering.

Manufacturer Narrative

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

• 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: 5725689
• MDR Text Key: 47417401
• Report Number: 2017233-2016-00573
• 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,Followup,Followup
• Report Date: 06/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/03/2018
• Device Catalogue Number: GSX0030A
• Device Lot Number: 14743870
• 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: 02/04/2016
• 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: 56 YR
• Patient Weight: 65