FDA.reportPublic FDA data

MAUDE MDR 5628203

MDR report key
5628203
Report number
2247686-2016-00005
Event key
0
Event type
3
Date of event
2016-02-09
Date received
2016-05-03
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
1
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.LXAAG730AG73010C031-011R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12016-05-0301. R

Event Narratives#

N

Patient 1

UPON FOLLOW-UP COMMUNICATIONS THE DOCTOR WAS ABLE TO VERIFY THE LOT NUMBER OF THE IMPLANTED ARTEGRAFT BASED ON THE PATIENT'S FILES. ARTEGRAFT, INC. PERFORMED A REVIEW OF THE BATCH HISTORY RECORDS; UPON RELEASE, THE BATCH MET ALL REQUIREMENTS INCLUDING STERILITY RESULTS. NOTE: UDI WAS NOT APPLICABLE AT THE TIME OF PRODUCT MANUFACTURE/RELEASE IN 2010. THE GRAFT WAS NOT RETURNED FOR EVALUATION AS IT REMAINS IMPLANTED. IT SHOULD BE NOTED THAT ANEURYSMS ARE LISTED IN THE CURRENT ARTEGRAFT, INC. INSTRUCTIONS FOR USE AS A KNOWN POTENTIAL ADVERSE REACTION. IN ADDITION, ARTEGRAFT'S CURRENT PATIENT INFORMATION GUIDE INSTRUCTS PATIENTS TO REQUEST THE DIALYSIS CAREGIVER TO ROTATE NEEDLE ACCESS SITES AND TO WATCH FOR ANY UNUSUAL COMPLICATIONS, SUCH AS "BALLOONING" OF THE GRAFT. A REVIEW OF COMPLAINT FILES IN THE PAST 2 YEARS WAS REVIEWED; NO TREND WAS IDENTIFIED FOR ANEURYSM. THE COMPLAINT ISSUE WILL CONTINUE TO BE MONITORED WITHIN ARTEGRAFT, INC. QUALITY SYSTEMS, QUALITY ASSURANCE TRENDING. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. GRAFT REMAINS IMPLANTED.

D

Patient 1

ARTEGRAFT, INC. RECEIVED AN EMAIL COMMUNICATION FROM AN AUTHORIZED DISTRIBUTOR, ON BEHALF OF THE DOCTOR, REQUESTING INFORMATION TO BE RELAYED BACK TO THE PATIENT. THE DOCTOR HAD COMPLETED A FEM-POP ON THE PATIENT ON (B)(6) 2010 UTILIZING AN ARTEGRAFT (COLLAGEN VASCULAR GRAFT); WITHIN A FEW YEARS, ANEURYSMS STARTED TO FORM IN THE ARTEGRAFT SO HE HAS BEEN WATCHING THE GRAFT CLOSELY SINCE THEN. THE DOCTOR FINALLY REPLACED THE GRAFT IN THE LAST MONTH [(B)(6) 2016] WITH PTFE. THE DOCTOR WAS "VERY SURPRISED AS THIS IS THE ONLY ARTEGRAFT HE'S HAD ISSUES WITH AFTER UTILIZING SEVERAL THOUSAND". THE DOCTOR WONDERED IF ARTEGRAFT, INC. WOULD BE ABLE TO TRACK THE GRAFT BACK TO THE LOT NUMBER FROM THE PATIENT'S IMPLANT DATE AND BE ABLE TO PROVIDE ANY FEEDBACK ON THE QUALITY CONTROL OF THE GRAFT THAT HE COULD SHOW TO THE PATIENT SHOWING THE INTEGRITY OF THE GRAFT. UPON FOLLOW UP COMMUNICATIONS, THE DOCTOR CLARIFIED THAT THE ARTEGRAFT WAS NOT EXPLANTED WHEN THE NEW PTFE GRAFT WAS IMPLANTED. HE AGREED TO REVIEW THE PATIENT OR FILES TO ATTEMPT TO IDENTIFY THE ARTEGRAFT LOT INFORMATION.