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

Catalog Number	HX2030
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No patient weight was available.
Event or Problem Description
It was reported a gore® helex septal occluder was implanted to close an atrial septal defect (asd) on (b)(6) 2014.On an unrelated follow-up exam to assess a surgical mitral valve repair, a wire fracture was noted on the left disc of the helex device.It was also noted that the lock loop was not capturing the right eyelet of the device and a significant shunt was observed.The physician said that during the future surgical procedure for the mitral valve repair, the device will be removed and the asd will be surgically closed.
Additional Manufacturer Narrative
New information from the hospital on 1/6/2019.The physician has no scheduled plan to remove the device.They are trying to let the patient grow a little more before the surgery to repair the mitral valve and device removal.A review of the imaging stated: a gore® helex septal occluder was implanted on (b)(6) 2014 to close an atrial septal defect.On an unrelated follow-up exam, a fluoroscopic image revealed a wire fracture on the superior edge of the left disc causing the disc to lose its configuration.In addition, a discontinuation of the locking mechanism was noted at the middle of the occluder between the center and left eyelets.The occluder remained stable.

• Brand Name: GORE HELEX SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER, SEPTAL OCCLUDER
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9370584
• Report Number: 2017233-2019-01183
• Device Sequence Number: 19549853
• Product Code: MLV
• UDI-Device Identifier: 00733132607006
• UDI-Public: 00733132607006
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050006
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2017
• Device Catalogue Number: HX2030
• Device Lot Number: 12368398
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 01/07/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 9 YR