Catalog Number TGU343420 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
|
Patient Problems
Claudication (2550); Vascular Dissection (3160); Not Applicable (3189)
|
Event Date 06/12/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
A review of the manufacturing records for the device verified the lot met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the conformable gore® tag® thoracic endoprosthesis may include but are not limited to vascular trauma and claudication.
|
|
Event Description
|
The following information was reported to gore: on (b)(6) 2016 a patient underwent treatment of a type b complicated aortic dissection with a conformable gore® tag® thoracic endoprosthesis.The maximum aortic diameter measured 46.4mm.On (b)(6) 2018 the patient exhibited left lower limb claudication and underwent an additional endovascular repair of the thoracic dissection.Additionally a left common iliac artery external iliac artery stent angioplasty was performed.The patient tolerated the procedure.
|
|
Event Description
|
The following information was reported to gore: on (b)(6), 2016 a patient underwent treatment of a type b complicated aortic dissection extending to the iliac arteries with a conformable gore® tag® thoracic endoprosthesis.The maximum aortic diameter measured 46.4mm.As part of the planned staged treatment for this patient, an axillary femoral bypass procedure was also performed.On (b)(6), 2018 the patient exhibited left lower limb claudication, which appeared to be related to true lumen compression in the left iliac system, and underwent an additional endovascular repair of the thoracic dissection with two conformable gore® tag® thoracic endoprostheses.Additionally the left common iliac artery was treated with a gore® viabahn® vbx balloon expandable endoprosthesis and the left external iliac artery was treated with a zilver stent.The patient tolerated the procedure.
|
|
Manufacturer Narrative
|
Updated.
|
|
Manufacturer Narrative
|
Upon further review of the event, there is no allegation against the gore devices.The additional procedures were part of a planned, staged treatment.Although the patient did experience claudication, the claudication was not an embolic or device related event.Rather it was related to compression in the iliac system.Medwatches # 2017233-2018-00652 were sent in error.Additional received information determined that this event is not reportable to the fda and therefore the medwatch and supplemental reports are being retracted.
|
|
Search Alerts/Recalls
|