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

Catalog Number TGT3115

Device Problem Bent (1059)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 08/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the report, on (b)(6) 2011, the patient underwent a left axillary artery-left common carotid artery-right axillary artery bypass procedure.It was reported, on (b)(6) 2011, the patient underwent endovascular repair of a thoracic aortic aneurysm with a gore® tag® thoracic endoprosthesis.The tag device was reportedly implanted with planned coverage of the left common carotid and the left subclavian artery.Final angiography showed exclusion of the aneurysm and no reported endoleak.The patient was reported to have tolerated the procedure.A routine computed tomography (ct) scan, performed on an unknown date in (b)(6) 2016, reportedly confirmed exclusion of the aneurysm.On an unknown date in (b)(6) 2017, follow-up imaging identified a suspected type iii endoleak with evidence of aneurysm enlargement, total amount of enlargement is reportedly unknown.Imaging reportedly showed the device ¿bent¿ with possible device breakage along the inner curve of the aorta.This ¿bending¿ is believed to have resulted from aortic remodeling after endovascular repair.On (b)(6) 2017, an intervention was performed to treat the suspected endoleak.Ballooning was performed utilizing a coda balloon catheter and a conformable gore® tag® thoracic endoprosthesis was implanted to reline the previously implanted tag device.According to the report, at the conclusion of the intervention final angiography was performed, however, imaging was unable to confirm resolution of the endoleak.The patient was reported to have tolerated the intervention.Images showing the endoleak were requested, however it was reported images are not available for evaluation.Gore is unable to confirm the allegation of possible device breakage as the device remains within the patient and therefore is not available for evaluation.

Manufacturer Narrative

(b)(4).

Event Description

Reportedly, at completion of the intervention performed on (b)(6) 2017, blood flow to the aneurysm persisted.The patient was reported to have tolerated the procedure.According to the report, on an unknown date, further examination determined the suspected endoleak was a type ii (source unknown) and not a type iii as previously reported.On (b)(6) 2017, the patient reportedly underwent catheter embolization to treat the type ii endoleak.According to the report, the procedure successfully resolved the endoleak.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: charlene cooper ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 6827703
• MDR Text Key: 83891261
• Report Number: 2017233-2017-00433
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• 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: 09/01/2017

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: 07/31/2014
• Device Catalogue Number: TGT3115
• Device Lot Number: 9468436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/29/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/17/2011
• 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: 82 YR