MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number TGU373720

Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Detachment of Device or Device Component (2907); Material Twisted/Bent (2981); Physical Resistance/Sticking (4012)

Patient Problems Death (1802); Obstruction/Occlusion (2422); Foreign Body In Patient (2687)

Event Date 11/12/2019

Event Type  Death  

Manufacturer Narrative

According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), potential adverse events or complications associated with the use of the gore® tag® thoracic endoprosthesis include, but are not limited to, access, delivery and deployment events (e.G.Access failure; deployment difficulties/failures; failure to deliver the stentgraft; and insertion or removal difficulty), catheter breakage, and death.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), "do not continue advancement or retraction of the guidewire, sheath, or delivery catheter if resistance is felt.".

Event Description

It was reported to gore on (b)(6) 2021 that this patient underwent reintervention for an aortic aneurysm on (b)(6) 2019 whereby a conformable gore® tag®thoracic endoprosthesis was implanted.It was further reported that during the procedure the leading olive of the conformable gore® tag®thoracic endoprosthesis separated and caused patient death.Through further investigation, the following information was reported to gore: this patient had previously underwent repair for an abdominal aortic aneurysm using a gore® excluder® aaa endoprosthesis on (b)(6) 2012.It was also reported that on an unknown date, the patient was also implanted with a non-gore aortic cuff.During the reintervention on (b)(6) 2019, it was noted that the non-gore aortic cuff had migrated distally.It was reported that during the reintervention when the delivery catheter of the first conformable gore® tag®thoracic endoprosthesis was being removed, the hospital staff that was attempting to remove the catheter felt a substantial amount of resistance.It was further reported that hospital staff continued to pull against the resistance with enough force to kink the super stiff guidewire, finally removing the catheter.According to the report, it was then observed that the leading olive had been separated and was left on the wire in the patients aorta.It was reported that after approximately 30-40 minutes of attempting to retrieve the leading olive using snares during which the olive tip was getting caught on the non-gore aortic cuff and causing the cuff to prolapse, hospital staff then attempted to retrieve the broken olive by advancing a q50 balloon alongside the leading olive to pin the tip to the top of the sheath.According to the report, the maneuver failed, and it was decided to monitor the olive and continue with the originally planned surgery of placing peripheral stents in the celiac and renal arteries.It was reported that during the continuation of the originally planned procedure it was observed the leading olive became lodged in the superior mesenteric artery.More attempts were made to remove the olive endovascularly while continuing the planned procedure, but failed.It was then decided to surgically remove the olive.The originally planned procedure that included a second gore® tag®thoracic endoprosthesis as well as peripheral stents continued, and the second device was implanted successfully.It was reported that the patient¿s condition deteriorated after surgery, and patient death occurred on (b)(6) 2019.It was reported that fluoroscopy had been turned off and on intermittently during the procedure including the removal of the device catheter, and due to this, the moment the leading olive was separated was likely not observed under fluorosocopy.It was additionally reported that the patient had tortuous anatomy with two 90 degree turns in the aorta.

Manufacturer Narrative

H6: updated results code for manufacturing evaluation.Conclusion code remains unchanged.

Manufacturer Narrative

B7: added medical history.H6: conclusion code remains unchanged.H6: updated type of investigation and investigation findings for engineering evaluation.H10/11: added medical record information.Additional details regarding the patient's clinical course were ascertained from a review of medical records and are as follows: key background information: date of placement: (b)(6) 2019.Dob (current age): (b)(6) 1944 (deceased).Dod (age at death): (b)(6) 2019 (75 years).Age at placement: 75 years.Implanting physician: (b)(6), md.State of residence: (b)(6).Occupational history: in construction and lifts heavy objects.Marital status: married.Alleged injuries: [ni] [not indicated].

Manufacturer Narrative

H6: health effect, medical device, and conclusion coding updated.Imaging evaluation findings: five image sets available for evaluation: abdominal x-ray dated on (b)(6) 2019 (no time stamp), angiogram imaging dated on (b)(6) 2019 (12:24:10), portable chest x-ray dated on (b)(6) 2019 (5:35 pm), portable chest/abdomen x-ray dated on (b)(6) 2019 (12:01 am), and a portable abdomen x-ray dated on (b)(6) 2019 (7:09am).Angiogram images provided do not include any device deployments.Cannot confirm the non-gore aortic cuff migrated with available imaging, however the cuff does appear distal to the renal arteries.No imaging was provided during removal of the conformable gore® tag® thoracic endoprosthesis delivery system, therefore, there is no imaging indication of the olive separation event.The olive does appear to be separated.Overall, images indicate an olive in the patient¿s sma prior to implantation of the celiac stent.Final angiograms and x-rays indicate complete visceral segment stenting after removal of olive.Engineering evaluation findings: no device evaluation could be performed as the conformable gore® tag® thoracic endoprosthesis (ctag) delivery catheter was not returned for evaluation.Per the imaging evaluation and the event description, it is likely that the olive was separated from the catheter due to the hospital staff continuing to pull against the resistance created by an interaction between the olive and the non-gore aortic cuff.The imaging evaluation and event description also indicate the reported resistance was not due to an interaction between the olive and the ctag endoprosthesis nor introducer sheath.Due to the reported intermittent use of fluoroscopy, the moment the leading olive was separated was likely not observed under fluoroscopy.This was confirmed in the significant time gaps missing from the imaging evaluation.It should be noted the warnings and precautions section of the ifu states if resistance is felt while retracting the delivery catheter ¿do not continue advancement or retraction of the guidewire, sheath, or delivery catheter if resistance is felt.Stop and assess the cause of resistance.Vessel, endoprosthesis, or delivery catheter damage may occur.¿ an additional warning in the warnings and precautions section of the ifu states ¿when catheters are in the body manipulate only under fluoroscopic guidance.¿ based on the available information, the reported separation of the leading olive from the delivery system was confirmed.A reason for olive separation from the delivery catheter during catheter removal is likely due to the hospital staff continuing to pull against the resistance created by an interaction between the olive and the non-gore aortic cuff.

• Brand Name: CONFORMABLE GORE TAGTHORACIC ENDOPROSTHESIS
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• MDR Report Key: 11346241
• MDR Text Key: 232510003
• Report Number: 2017233-2021-01684
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618194
• UDI-Public: 00733132618194
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/25/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/17/2022
• Device Model Number: TGU373720
• Device Catalogue Number: TGU373720
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2019
• Initial Date FDA Received: 02/18/2021
• Supplement Dates Manufacturer Received: 02/09/2021; 03/24/2021; 07/26/2021
• Supplement Dates FDA Received: 03/16/2021; 04/13/2021; 08/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 75 YR