MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGU454520J

Device Problem Unintended Movement (3026)

Patient Problem Aneurysm (1708)

Event Date 11/15/2018

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: as gore was unable to determine which device was involved in the event if any, additional device(s) implanted include: tgu343415j/lot number unknown, no udi available.According to the instructions for use (ifu) for the gore® tag® thoracic endoprosthesis; adverse events that may occur include, but are not limited to include: endoleak, endoprosthesis: migration a review of the manufacturing records for the device(s) was unable to be conducted as the lot number(s) were unavailable.

Event Description

On (b)(6) 2018, this patient underwent endovascular treatment for a thoracic aortic aneurysm pending rupture, and was implanted with conformable gore® tag® thoracic endoprostheses and an axillary-axillary artery bypass and one debranch was performed.At the conclusion of the procedure a proximal type i endoleak persisted.The patient tolerated the procedure and declined additional treatment for the endoleak and will undergo monitoring by the physician.On an unknown date, a follow-up examination revealed possible aneurysm enlargement.On (b)(6) 2019, follow-up computed tomography determined enlargement of the aneurysm (amount unknown).The physician reported at this time that the proximal type i endoleak persisted, the device had migrated distally (distance unknown).On (b)(6) 2019, the patient underwent reintervention and the left common carotid artery (lcca)was bypassed and tethered to the original axillary-axillary artery bypass.A gore® excluder® internal iliac branch component was then implanted within the brachiocephalic artery using a chimney technique and both the lcca and brachiocephalic artery were intentionally covered with a additional conformable gore® tag® thoracic endoprostheses.The patient tolerated the procedure and the endoleak was resolved.

Manufacturer Narrative

D11: as gore was unable to determine which device was involved in the event if any; additional device(s) implanted include: tgu343415j/17900217, udi: (b)(4).H6: code 213 further investigation returned the lot numbers for the devices involved in this event, a review of the manufacturing records for the devices verified that the lots met all pre-release specifications.

• Brand Name: CONFORMABLE GORE TAG THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8392186
• MDR Text Key: 137881949
• Report Number: 2017233-2019-00125
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/28/2019

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: 09/13/2020
• Device Catalogue Number: TGU454520J
• Device Lot Number: 17310223
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 62 YR