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

Catalog Number	TGU404015
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2018, a conformable gore® tag® thoracic endoprosthesis (item/lot not available) was to be implanted as part of a thoracic endovascular aortic repair.According to the report, the gore® tag® device could not be advanced to its target location.The decision was made to withdraw the delivery catheter.Upon device withdrawal, the gore® dryseal sheath (item/lot not available) valve was reportedly ruptured.After the device was withdrawn, it was reported the physician noticed a metal protrusion from the leading olive at the tip of the delivery catheter.The sheath was removed and replaced, and a new ctag of the same catalog number was used to continue the procedure.The procedure went forward to completion without any further reported issues.The patient tolerated the procedure.
Event or Problem Description
On (b)(6), 2018, a conformable gore® tag® thoracic endoprosthesis was to be implanted as part of a thoracic endovascular aortic repair.According to the report, the conformable gore® tag® (ctag) device could not be advanced to its target location.The decision was made to withdraw the delivery catheter.Upon device withdrawal, the gore® dryseal sheath (item/lot not available) valve was reportedly ruptured.After the device was withdrawn, it was reported the physician noticed a metal protrusion from the leading olive at the tip of the delivery catheter.The sheath was removed and replaced, and a new ctag of the same catalog number was used to continue the procedure.The procedure went forward to completion without any further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
Correction: event-conformable gore® tag® (ctag) thoracic endoprosthesis lot/serial number was obtained.Code 3253.Code 4315-the conformable gore® tag® (ctag) thoracic endoprosthesis was returned to gore for evaluation, the aortic introducer sheath (dryseal) was not returned for evaluation.The ctag device evaluation showed the leading end of the stiffening wire was protruding through the soft tip of the leading olive.The guidewire was unable to advance through the entire device due to an obstruction near the leading olive.The findings from the evaluation are consistent with the event description indicating that a metal protrusion from the leading olive at the tip of the delivery catheter was present.The description of a metal protrusion is consistent with the stiffening wire.The root cause for why stiffening wire was protruding from the soft tip of the leading olive could not be determined from the available information.
Additional Manufacturer Narrative
Correction b2 was populated in error.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7875169
• Report Number: 2017233-2018-00553
• Device Sequence Number: 19348317
• Product Code: MIH
• UDI-Device Identifier: 00733132618163
• UDI-Public: 00733132618163
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/19/2018

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: 05/10/2020
• Device Catalogue Number: TGU404015
• Device Lot Number: 16340641A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 09/13/2018
• Supplement Report FDA Received Date: 11/20/2018; 12/21/2018
• 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: Life Threatening