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

Catalog Number GSX0030A

Device Problem Insufficient Information (3190)

Patient Problem Complete Heart Block (2627)

Event Date 12/23/2015

Event Type  Injury  

Manufacturer Narrative

A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The device remains implanted so no engineering investigation could be performed.

Event Description

It was reported the physician implanted a gore cardioform septal occluder.Following the procedure the patient present in complete heart block.The patient was hospitalized overnight and released the following day on steroids and a heart monitor.A follow up was conducted on 12/29/2015 and the patient was in sinus rhythm.

Manufacturer Narrative

(b)(4).

• 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 86001
• Manufacturer Contact: ashley marostica ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 5371493
• MDR Text Key: 36208746
• Report Number: 2017233-2016-00060
• 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
• Report Date: 01/25/2016

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2017
• Device Catalogue Number: GSX0030A
• Device Lot Number: 14483540
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/25/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/03/2015
• 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): Other
• Patient Age: 18 YR