FDA.reportPublic FDA data

MAUDE MDR 5750026

MDR report key
5750026
Report number
2247686-2016-00008
Event key
0
Event type
3
Date of event
2016-05-27
Date received
2016-06-25
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
CYNTHIA SALTER
Address
206 NORTH CENTER DRIVE NORTH BRUNSWICK NJ 08902 US
Phone
732-732-7324
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1ARTEGRAFTCOLLAGEN VASCULAR GRAFTARTEGRAFT, INC.LXAAG745AG74515D102-014R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-06-2501. R

Event Narratives#

N

Patient 1

ARTEGRAFT, INC. PERFORMED A REVIEW OF THE BATCH HISTORY RECORD. UPON RELEASE, THE BATCH MET ALL REQUIREMENTS INCLUDING PRESSURE TEST RESULTS AND GRAFT WALL THICKNESS. PRODUCT EVALUATION WAS NOT ABLE TO BE PERFORMED AS THE GRAFT REMAINS IMPLANTED AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION. PHOTOGRAPHS OF THE SURGERY PRIOR TO THE SUTURE OF THE GRAFT "SLIT" WERE PROVIDED; HOWEVER, NO CONCLUSIONS WERE ABLE TO BE MADE BASED ON THE IMAGES. TO DATE, NO ADDITIONAL COMPLAINTS WERE REPORTED FROM THE SAME PRODUCT BATCH AND NO COMPLAINTS FOR THE SAME ISSUE OF IMPLANTED GRAFT "BLOW OUT' WERE RECEIVED IN THE PAST 2 YEARS. IT IS UNKNOWN IF PROCEDURAL ISSUES AND/OR PATIENT INTERACTION CONTRIBUTED TO THE REPORTED EVENT. THE COMPLAINT ISSUE WILL CONTINUE TO BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING. GRAFT REMAINS IMPLANTED.

D

Patient 1

AN ARTEGRAFT, INC. APPROVED DISTRIBUTOR REPORTED ON BEHALF OF THE VASCULAR SURGEON THAT AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT) WHICH WAS IMPLANTED A "COUPLE OF WEEKS AGO" "BLEW OUT"; A HOLE WAS NOTICED IN THE SIDE OF THE GRAFT. UPON FOLLOW-UP COMMUNICATIONS, IT WAS STATED THAT THE PATIENT PREVIOUSLY HAD BLOOD FLOW ISSUES AND AS A RESULT, LOST TOES DUE TO FAILED LIMB SALVAGE. THE ARTEGRAFT WAS IMPLANTED IN THE PATIENT'S RIGHT FEMORAL TO POPLITEAL DURING A LIMB SALVAGE PROCEDURE ON (B)(6) 2016. THE REPORTER WAS UNSURE IF THE ARTEGRAFT IFU REQUIRED STEP FOR PRE-IMPLANT PRESSURE TESTING WAS PERFORMED BY THE SURGICAL TEAM. IT WAS ALSO STATED THAT THIS WAS THE HOSPITALS FIRST ATTEMPT AT USING AN ARTEGRAFT IN A LOWER EXTREMITY. A FEW WEEKS AFTER THE SURGERY, THE PATIENT ALLEGED NOTICEABLE IRRITATION UNDER THE SKIN IN THE GRAFT LOCATION. THE SURGEON INITIALLY ATTEMPTED TO PLACE A VASCULAR STENT HOWEVER, IT FAILED IN PERFORMANCE. FURTHER EXAM IDENTIFIED A GRAFT RUPTURE. WHEN THE PATIENT'S LEG WAS OPERATED ON (B)(6) 2016, COAGULATED BLOOD WAS SEEN AND ABOUT 3 CM FROM THE ANASTOMOSIS THERE WAS A ~1 CM "SLIT" IN THE GRAFT. THE SURGEON WAS ABLE TO SUCCESSFULLY SUTURE THE "SLIT" IN THE GRAFT. THE GRAFT REMAINS IMPLANTED AND THE PATIENT IS REPORTED TO BE IN STABLE CONDITION.