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

Catalog Number TGM262610E

Device Problem Difficult to Remove (1528)

Patient Problem Infarction, Cerebral (1771)

Event Date 02/22/2020

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.Post-implantation non- contrast computed tomography (ct) images, dated (b)(6) 2020, were provided to w.L.Gore & associates for evaluation.The imaging evaluation showed the following results: since the imaging provided for evaluation is a non-contrast ct, the images cannot be evaluated for thrombus, actual flow lumen irregularities or endoleaks.There appears to be two gore® tag® conformable thoracic stent grafts implanted.The proximal device appears to be in the thoracic aortic arch extending into the descending thoracic aorta (dta).The distal device appears to have approx.2.7 cm of overlap and extends more distal in the dta.Length of the proximal device appears to be approx.9.4 cm, by outer curve length.Length of the distal device appears to be approx.9.5cm, by outer curve length.It is unclear if any stent row was cut due to the resolution of the imaging; however there is some indication that a proximal apex on the proximal device may be deformed.The inner curve of the proximal devices appears to be non-uniform.

Event Description

It was reported that the patient presented with an aortic trauma and was treated with a gore® tag® conformable thoracic stent graft with active control system.It was stated that after the device was deployed, it was not possible to remove the catheter from the patient or to push it more proximally.In both situations the catheter would move the device either distal or proximal.It was stated that the deployment step was normal and that no unusual resistance was felt during any of the steps of the deployment.The deployment line access hatch was opened to check if all lines and wires were removed.No lines/wires were visible.Additionally it was tried to separate the catheter from the endoprosthesis by rotating the catheter and by ballooning.The attempts were also unsuccessful.Finally the physician decided to disconnect the catheter from the device in a surgical approach.The catheter and the guidewire were cut and removed afterwards.It was stated that the endoprosthesis did not migrate and remained at the intended position sealing the traumatic injury.The patient tolerated the procedure, but is suffering from a stroke.

Manufacturer Narrative

The device catheter was returned to w.L.Gore & associates for evaluation.The device evaluation showed the following: damage to the curved olive indicates that a proximal apex was wedged between the olive and delivery catheter.A wedged apex can prevent the catheter from disengaging from the device post deployment.The findings of the evaluation are consistent with the physician¿s observation that a proximal apex was caught on the delivery catheter, preventing the catheter from being removed following deployment.The catheter remaining attached to the endoprosthesis following deployment can be attributed to the proximal apex that was wedged between the catheter and olive, which did not separate during deployment.Based on the evaluation, the cause of the proximal apex being wedged between the catheter and olive appears to be attributable to the manufacturing process.The worst-case severity of harm that is reasonably foreseeable for this scenario is serious.

Manufacturer Narrative

B5: updated event description.H6: corrected conclusion code 1 to 25.

Event Description

It was reported that the patient presented with an aortic trauma and was treated with a gore® tag® conformable thoracic stent graft with active control system.It was stated that after the device was deployed, it was not possible to remove the catheter from the patient or to push it more proximally (coded 1808-e).In both situations the catheter would move the device either distal or proximal.It was stated that the deployment step was normal and that no unusual resistance was felt during any of the steps of the deployment.The deployment line access hatch was opened to check if all lines and wires were removed.No lines/wires were visible.Additionally it was tried to separate the catheter from the endoprosthesis by rotating the catheter and by ballooning.The attempts were reported to be unsuccessful.Finally it was decided to disconnect the catheter from the device in a surgical approach.The catheter and the guidewire were cut and removed afterwards.It was stated that the endoprosthesis did not migrate and remained at the intended position sealing the traumatic injury.The patient had two foci of bleeding at the brain level caused by the longtime of heparinization.Additionally paraparesis without spinal involvement was reported.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9864291
• MDR Text Key: 196573703
• Report Number: 2017233-2020-00205
• 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,Followup
• Report Date: 08/03/2020

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: 11/25/2021
• Device Catalogue Number: TGM262610E
• Device Lot Number: 20757770
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/23/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/22/2020; 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 31 YR