MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGMR404020
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment of a thoracic aortic aneurysm using a gore® tag® conformable thoracic endoprosthesis with active control.The physician advanced the sheath slowly until he felt resistance.He stopped advancing the gore® dryseal flex introducer sheath at the proximal end of the right external iliac artery.The right external iliac artery measured 5.5mm-6mm.The right common iliac artery measured 8mm.The physician then started to introduce the ctag/ac through the sheath and then outside the sheath through the right common iliac artery.Resistance was felt but he kept advancing the device slowly until passed the right common iliac artery and the aortic bifurcation and reached the thoracic aorta.When the device was in the desired location, it was observed the patient¿s blood pressure dropped.It was discovered that the right common iliac artery had ruptured.(this was reported on mfr report # 3007284313-2021-01425).At that moment the physician started the steps to deploy the device quickly.After the first 50% was deployed the fsa noticed that the distal end had not deployed, but the physician kept following the deployment steps to fully deploy the device.All the normal deployment steps had been taken, however approximately 2 cm of the distal end of the device remained constrained.Due to that, blood flow to the iliac arteries were reduced.The physician then opened the deployment line access hatch, but no fibers were visible.Therefore, a balloon was introduced via the brachial artery.The physician tried to pass a wire through the undeployed portion of the device.The physician tried different wires and catheters.Finally, they used a 12 mm bard conquest balloon to gain access and the distal portion of the device was fully deployed.
Additional Manufacturer Narrative
Engineering evaluation: a limited evaluation could be performed as the white handle and pieces of the delivery catheter were the only components returned for evaluation.Therefore, the event description of the incomplete primary deployment and resistance could not be confirmed.Per the manufacturing product history review (phr), mpdcase-00003950-1, the device met all pre-release specifications and at the time of manufacturing there were no capas or ncrs related to this event.A reason for the incomplete primary deployment or resistance cannot be determined with the available information.Based on this investigation, there is no evidence to suggest a manufacturing deficiency.

• Brand Name: GORE TAG CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11813866
• Report Number: 2017233-2021-01991
• Device Sequence Number: 3910555
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: 00733132646852
• Combination Product (Y/N): N
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/23/2021

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: 07/25/2023
• Device Model Number: TGMR404020
• Device Catalogue Number: TGMR404020
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/13/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 05/12/2021
• Supplement Report FDA Received Date: 09/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR