MAUDE MDR 3035523

MDR report key
3035523
Report number
2017233-2013-00183
Event key
0
Event type
3
Date of event
2012-03-13
Date received
2013-03-27
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
LAURA CRAWFORD
Address
32470 N. NORTH VALLEY PARKWAY PHOENIX AZ 85085 US
Phone
925-925-9255
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GORE TAG THORACIC ENDOPROSTHESISMIH / SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENTW.L. GORE & ASSOCIATESMIHTG4510R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12013-03-270

Event Narratives#

D

Patient 1

AN ARTICLE PUBLISHED BY THE 2012 EUROPEAN JOURNAL OF VASCULAR AND ENDOVASCULAR SURGERY 2013;45(1):28-35, TRIPLE-BARREL GRAFT AS A NOVEL STRATEGY TO PRESERVE SUPRA-AORTIC BRANCHES IN ARCH-TEVAR PROCEDURES: CLINICAL STUDY AND SYSTEMATIC REVIEW REVIEWED THE OUTCOMES OF EARLY EXPERIENCE WITH TOTAL ENDOVASCULAR REPAIR OF AORTIC-ARCH ANEURYSM USING DOUBLE CHIMNEY-GRAFTS. AVAILABLE ONLINE (B)(4) 2012. IN REVIEW OF THE PUBLISHED LITERATURE THE FOLLOWING FINDINGS WERE NOTED: DURING (B)(6) 2010 THROUGH (B)(6) 2012 THE DOUBLE CHIMNEY-GRAFT TECHNIQUE WAS PERFORMED IN SIX MALE PATIENTS ((B)(6)), WITH CONTAINED RUPTURED ANEURYSM, DISSECTING ANEURYSM, PSEUDOANEURYSM, PENETRATING AORTIC ULCER AND PROXIMAL ENDOLEAK AFTER TEVAR. IN ALL CASES, ALL SUPRA-AORTIC VESSELS HAD TO BE COVERED WITH AORTIC STENT-GRAFT TO RECEIVE A SUFFICIENT LANDING AND SEALING ZONE. CHIMNEY-GRAFTS WERE INTRODUCED TO THE ASCENDING AORTA SLIGHTLY DEEPER THAN THE THORACIC STENT-GRAFTS THROUGH THE CUT-DOWN EXPOSURE OF THE COMMON CAROTID ARTERIES. WE DEPLOYED AORTIC STENT GRAFTS AND SELF-EXPANDABLE CHIMNEY-GRAFTS SIMULTANEOUSLY AND SUCCESSFULLY. THE USE OF DOUBLE CHIMNEY-GRAFTS IS POSSIBLE IN HIGH-RISK PATIENTS WHERE THE PROXIMAL LANDING ZONE OF ENDOGRAFT WOULD BE IN ZONE 0. THE ARTICLE REPORTS PATIENT NUMBER FOUR UNDERWENT REPAIR WITH GORE TAG THORACIC ENDOPROSTHESIS ON (B)(6) 2012. THE PATIENT TOLERATED THE PROCEDURE. ON (B)(6) 2012, PATIENT UNDERWENT RE-INTERVENTION AND ADDITIONAL AORTIC STENT-GRAFT WAS PLACED FURTHER PROXIMALLY IN THE ASCENDING AORTA. ADDITIONAL BALLOON MODELING OF ALL STENT-GRAFTS WAS PERFORMED AND THE ENDOLEAK RESOLVED. TWO YEAR LATER, THIS PATIENT PRESENTED WITH CHEST PAIN AND AN INFECTED STERNAL FISTULA WITH BLOOD SECRETION. THE CT REVEALED A PSEUDOANEURYSM OF AORTIC ARCH FROM THE CANNULATION POINT DURING THE CABG CONNECTED TO THE STERNAL FISTULA.

N

Patient 1

CONCLUSIONS: ACCORDING TO THE GORE TAG THORACIC ENDOPROSTHESIS INSTRUCTIONS FOR USE, THE GORE TAG THORACIC ENDOPROSTHESIS IS INTENDED FOR ENDOVASCULAR REPAIR OF ANEURYSMS OF THE DESCENDING THORACIC AORTA. THE GORE TAG THORACIC ENDOPROSTHESIS IS DESIGNED TO TREAT PROXIMAL AND DISTAL AORTIC NECK LENGTHS NO LESS THAN 20 MM DISTAL TO EITHER THE LEFT SUBCLAVIAN OR LEFT COMMON CAROTID ARTERY WITH A REQUIRED MINIMUM 20 MM HEALTHY PROXIMAL AND DISTAL NECK LENGTHS. THE LOT/SERAL NUMBER WAS REQUESTED BUT WAS NOT AVAILABLE. THEREFORE, GORE WAS NOT ABLE TO DETERMINE IF ANY OF THESE EVENTS WERE PREVIOUSLY REPORTED. ADDITIONAL DEVICE IMPLANTED INCLUDES: TGE454515/UNK.