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

Catalog Number TGE282815

Device Problems Difficult to Fold, Unfold or Collapse (1254); Material Fragmentation (1261); Difficult to Remove (1528); Difficult to Advance (2920)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2017

Event Type  malfunction  

Manufacturer Narrative

Udi for conformable gore® tag® thoracic endoprosthesis tge282815: (b)(4).The review of the manufacturing paperwork verified that the lot involved in this event met all pre-release specifications.(b)(4).

Event Description

The following was reported to gore: on (b)(6) 2017, this patient underwent thoracic endovascular repair and was treated with three conformable gore® tag® thoracic endoprostheses.Prior to the thoracic repair procedure, the patient was implanted with an iliac stent to maintain patency of the access vessel.When a gore® dryseal sheath was inserted into the access vessel and thus through the iliac stent, it seems that the stent was unknowingly dislodged and advanced to the treatment area.Subsequently, and seemingly unaware of the iliac stent location, the physician advanced the device catheter of the first tge282810 to the treatment area and through the iliac stent.The device was observed to open with an hour-glass shape with the distal part deploying first, followed by the proximal part with a delay of about 30 seconds.Prior to full proximal deployment, the device was observed to have moved distally for a length of about 10 cm during the deployment.Subsequently, and to gain proximal seal zone, the physician managed to advance a second tge282815 component through the constrained portion of the tge282810 device beyond the iliac stent, resulting in deployment of the most proximal as well as the distal part of the tge282815 device, while its middle part was likewise constrained by the iliac stent.In an attempt to fully release the second tge282815 device from the catheter, a balloon was used which also assumed a prominent hour-glass shape.It was additionally noticed that the forces of the inflation foreshortened the length of the iliac stent.However, the leading olive entirely separated when retracting the tge282815 component catheter in a spatially confined environment with also the balloon catheter and other wires present.The leading olive came to rest in the ascending aorta in proximity to the aortic valve and was not retrieved.The proximal endoleak was repaired by advancing at third tge343410 component which was deployed without issues at the intended location but still showing a narrowing in its mid section.Finally, and to expand the confinement caused by the iliac stent, a palmaz device was advanced to the iliac stent location and deployed.The patient tolerated the procedure.

Manufacturer Narrative

Additional conformable gore® tag® thoracic endoprostheses involved in this event: (b)(4).The review of the manufacturing records verified that the lots involved in this event met all pre-release specifications.The following is a summary of the ei observations: tissue present: yes.Minimal, scattered plaques of friable red/brown and yellow material were present on the abluminal and luminal surfaces.All lumens were patent.Ctag-2 (proximal) and ctag-1 were in an overlapping configuration with a severely compressed bare metal stent present on the albumen of the overlapping region, which presented in an hour glass configuration.The abluminal stent was constricting the lumens of the overlapping ctag devices.This was reported to be a migrated iliac stent, which was implanted at the time of the procedure to facilitate introduction of the introducer sheath, (type and manufacturer of the iliac stent was not provided).Present overlapping the luminal area of constriction was an additional bare metal stent (palmaz® by cordis®).The lumen was narrowed in diameter but remained widely patent.Ctag-3 was separated from the system and primarily devoid of tissue at the proximal aspect (approximately four rows).The third row wire is displaced and partially separated from underlying graft material.Material disruptions in conjunction with proximal area being primarily devoid of tissue suggests an area of graft overlap and damage was likely caused during graft separation.From gross images and information provided material disruptions noted (i.E., wire displacement), appear to be consistent with grasping/pulling with surgical instrumentation (i.E., hemostat or forceps), likely used during the explant procedure.Abnormal contour of the devices appear to have resulted from interaction with the migrated iliac stent.Request for additional analysis: no.Reason: the devices were explanted due to an infection and as the device was not properly fixed upon removal; no additional histology will be performed.The deployment difficulties reported are associated with the migration of an iliac stent and are not directly associated with the ctag devices.Based on the ei's review of the geprovas report, no additional analysis is requested.

Manufacturer Narrative

(b)(4).The review of the manufacturing records verified that the lots involved in this event met all pre-release specifications.Date of event: changed date for this follow-up event.Describe event or problem: corrected parts of event description.Type of reportable event: changed to serious injury.Device evaluated by manufacturer?: changed to "yes".

Event Description

The following was reported to gore: on (b)(6) 2017, this patient underwent an emergency thoracic endovascular repair to treat an oesophageal fistula that appeared after a resection of the oesophagus due to an endocarcinoma.The patient was therefore treated with three conformable gore® tag® thoracic endoprostheses.On (b)(6) 2018, all three conformable gore® tag® thoracic endoprostheses were explanted along with the iliac stent and the palmaz stent.

Manufacturer Narrative

Additional event description.Correction: a gore® dry seal flex introducer sheath was used in the procedure, not a gore® dryseal sheath with hydrophilic coating as previously reported.The conformable gore® tag® thoracic endoprosthesis (b)(4) was not returned as it was discarded at the facility.Therefore, an engineering investigation could not be performed.

Event Description

On (b)(6) 2018, it was reported that the leading olive continues to remain in the anatomical location mentioned afore as there appears to be no clinical significance.A re-intervention has been considered to be performed at some later date to possibly explant the thoracic device together with the palmaz stent.

Manufacturer Narrative

The review of the manufacturing records verified that the lot involved in this event met all pre-release specifications.The device catheter of the conformable gore® tag® thoracic endoprosthesis (b)(4) was not returned as it was discarded at the facility.Therefore, an engineering investigation could not be performed.Please note: this medwatch report for event# (b)(6) was created in error as a follow-up report to our event# (b)(6) and will be closed with the information provided in event# (b)(6).The information provided in this report was therefore corrected.For the reported infection and the subsequent explant procedure, the information will be reported with new mfr report # 2017233-2020-00430.

Event Description

The following information was reported to gore: on (b)(6) 2017, this patient underwent thoracic endovascular repair and was treated with three conformable gore® tag® thoracic endoprostheses.Prior to the thoracic repair procedure, the patient was implanted with an iliac stent to maintain patency of the access vessel.When a gore® dry seal flex introducer sheath was inserted into the access vessel and thus through the iliac stent, it seems that the stent was unknowingly dislodged and advanced to the treatment area.Subsequently, and seemingly unaware of the iliac stent location, the physician advanced the device catheter of the first (b)(4) to the treatment area and through the iliac stent.The device was observed to open with an hour-glass shape with the distal part deploying first, followed by the proximal part with a delay of about 30 seconds.Prior to full proximal deployment, the device was observed to have moved distally for a length of about 10 cm during the deployment.Subsequently, and to gain proximal seal zone, the physician managed to advance a second (b)(4) component through the constrained portion of the (b)(4) device beyond the iliac stent, resulting in deployment of the most proximal as well as the distal part of the (b)(4) device, while its middle part was likewise constrained by the iliac stent.In an attempt to fully release the second (b)(4) device from the catheter, a balloon was used which also assumed a prominent hour-glass shape.It was additionally noticed that the forces of the inflation foreshortened the length of the iliac stent.However, the leading olive entirely separated when retracting the (b)(4) component catheter in a spatially confined environment with also the balloon catheter and other wires present.The leading olive came to rest in the ascending aorta in proximity to the aortic valve and was not retrieved.The proximal endoleak was repaired by advancing at third (b)(4) component which was deployed without issues at the intended location but still showing a narrowing in its mid section.Finally, and to expand the confinement caused by the iliac stent, a palmaz device was advanced to the iliac stent location and deployed.The patient tolerated the procedure.On (b)(6) 2018, it was reported that the leading olive continues to remain in the anatomical location mentioned afore as there appears to be no clinical significance.A re-intervention has been considered to be performed at some later date to possibly explant the thoracic device together with the palmaz stent.

Manufacturer Narrative

The conformable gore® tag® thoracic endoprosthesis instructions for use (ifu) states: do not continue if resistance is felt during advancement of the guidewire, sheath, or delivery catheter.Stop and assess the cause of resistance.Vessel or delivery catheter damage may occur.According to the gore® tag® thoracic endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to: material failure.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: thomas giebing ; 1500 n. 4th street; flagstaff, AZ ; 9285263030
• MDR Report Key: 7144180
• MDR Text Key: 96028493
• Report Number: 2017233-2017-00672
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/30/2020
• Device Catalogue Number: TGE282815
• Device Lot Number: 16231646
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 04/18/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/31/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR
• Patient Weight: 90