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

Model Number	TGMR313115
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Vascular Dissection (3160)
Date of Event	03/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specifications.
Event or Problem Description
On (b)(6) 2020, the patient was implanted with a conformable gore® tag® thoracic endoprosthesis and a gore® tag® conformable thoracic stent graft with active control system to treat a dissection.It was reported that prior to the devices being implanted, there was an open surgical repair of the total aortic root and an aortic arch replacement.Once the elephant trunk was in place, the physician wanted to extend distally into the descending thoracic aorta with a gore endoprosthesis.The conformable gore® tag® thoracic endoprosthesis was implanted with no issue.When implanting the gore® tag® conformable thoracic stent graft with active control system, the primary sleeve deployed without incidence.Upon attempting to deploy the secondary sleeve (trailing to leading end) would not release.The physician stated that the ¿red handle snapped and the delivery catheter would not release from the device¿.The physician had access due to the open repair, and was able to cut the lockwire and angulation fibers to release the delivery catheter from the device and remove from the patient.The device was advanced over a wire via direct placement from the arch (open repair of ascending) aka frozen elephant procedure.A sheath was not involved.The device was advanced bare via direct placement (due to elephant trunk procedure allowing access as such).The device was implanted successfully and there was no consequences or injury to the patient.The patient tolerated the procedure.
Additional Manufacturer Narrative
Addition the device was returned to gore for evaluation.Per the evaluation the secondary deployment line appeared cut and shorter than expected for a fully deployed gore® tag® conformable thoracic stent graft with active control system (tgmr313115) device.The lockwire was broken at the lockwire handle and appeared cut near the catheter transition.The angulation connector was disconnected from the device and the fibers appeared cut close to the connector.Based on the event description and device evaluation, no manufacturing deficiencies could be confirmed.Addition h6: code 22-the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) states that adverse events that may occur and/or require intervention include, but are not limited to catheter breakage.
Additional Manufacturer Narrative
Correction-fields h7 and h9 were incorrectly filled in and should be blank.Correction-say this event is not related to field action number 2017233.09/09/2020.001-c.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9919054
• Report Number: 2017233-2020-00230
• Device Sequence Number: 14270950
• Product Code: MIH
• UDI-Device Identifier: 00733132646784
• UDI-Public: 00733132646784
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Remedial Action: Notification
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/02/2020

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: 02/13/2022
• Device Model Number: TGMR313115
• Device Catalogue Number: TGMR313115
• Device Lot Number: 20936124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided; Not provided
• Initial Report FDA Received Date: 04/02/2020
• Supplement Report FDA Received Date: 08/26/2020; 09/16/2020; 10/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 2017233.09/09/2020.001-C
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 69 YR
• Patient Weight: 77