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U.S. Department of Health and Human Services

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

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W.L. GORE & ASSOCIATES CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT Back to Search Results
Catalog Number TGU454515
Device Problems Difficult or Delayed Positioning (1157); Human-Device Interface Problem (2949)
Patient Problem Occlusion (1984)
Event Date 03/27/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).A review of the manufacturing records for the device verified that the lot met all pre-release specifications.The conformable gore® tag® thoracic endoprosthesis instructions for use (ifu) state ¿advance the endoprosthesis past the target location and pull back to desired position to release stored energy in the system¿.Per ifu, complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but are not limited to improper endoprosthesis placement and branch vessel occlusion or obstruction.
 
Event Description
On (b)(6) 2018, the patient was implanted with two conformable gore® tag® thoracic endoprostheses as part of a thoracic endovascular aortic repair.During the procedure, the proximal endoprosthesis (tgu454515/17578537) was to be implanted at the distal ostium of the left common carotid artery (lcca).Upon deployment, the device partially and unintentionally covered the lcca.The physician believes the vessel coverage occurred because stored energy in the delivery catheter was not sufficiently removed by drawing the catheter back far enough prior to deployment.Although the lcca reportedly still had blood flow, the physician decided to implant a viabahn® balloon expandable stent in the lcca via antegrade approach.The patency of the vessel was preserved, and the procedure was concluded.The patient tolerated the procedure.
 
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Brand Name
CONFORMABLE GORE® TAG® THORACIC ENDOPROSTHESIS
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
damon jackson
1500 n. 4th street
flagstaff, AZ 
9285263030
MDR Report Key7415609
MDR Text Key105133433
Report Number2017233-2018-00211
Device Sequence Number1
Product Code MIH
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P040043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/27/2018
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 Date11/27/2020
Device Catalogue NumberTGU454515
Device Lot Number17578537
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/10/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age70 YR
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