FDA.reportPublic FDA data

MAUDE MDR 6812896

MDR report key
6812896
Report number
3008250974-2017-00001
Event key
0
Event type
3
Date of event
2017-07-26
Date received
2017-08-23
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
MRS. JULIE THOMAS
Address
2621 RIDGEPOINT DR. SUITE 100 AUSTIN TX 78754 US
Phone
512-512-5129
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HAART 300 AORTIC ANNULOPLASTY DEVICEANNULOPLASTY RINGBIOSTABLE SCIENCE & ENGINEERINGPSTHAART 300300-2101-00149N Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-2301. H; 2. R

Event Narratives#

N

Patient 1

THE PARTIAL DEHISCENCE OF THE HAART 300 DEVICE IN THE AREA OF THE RIGHT CORONARY CUSP COULD ONLY RESULT FROM A FAILURE OF THE IMPLANTATION SUTURES USED TO SECURE THE DEVICE TO THE ANNULUS IN THAT REGION. THREE DIFFERENT FAILURE MECHANISMS ARE PLAUSIBLE: THE SUTURES MAY HAVE BROKEN UNDER TENSION, THE SUTURE KNOTS MAY HAVE COME UNTIED, OR THE SUTURES PULLED THROUGH THE ANNULAR TISSUES. DR. (B)(6) REPORTED THAT THERE WAS NO EVIDENCE THAT THE SUTURES TORE THROUGH THE ANNULUS., AND NO AI JET WAS PRESENT OUTSIDE THE VALVE LEAFLETS AS EVALUATED BY ECHOCARDIOGRAM. THE SUTURES WERE TIED OVER 3MM X 7MM POLYESTER PLEDGETS TO AUGMENT THE STRENGTH OF THE SUTURE LINE AND THERE IS NO EVIDENCE THAT THE PLEDGETS TORE THROUGH THE ANNULAR TISSUES. BREAKAGE OF THE SUTURES IS ALSO HIGHLY UNLIKELY. THE 4.0 PROLENE SUTURES USED TO IMPLANT THE DEVICE HAVE AN ULTIMATE FAILURE LOAD OF NEARLY 18 N (4 LBF) (B)(4). TWO SUTURES ARE USED IN THE REGION OF THE RIGHT CORONARY CUSP AND EACH SUTURE IS WRAPPED AROUND THE FRAME SUCH THAT 4 STRANDS OF PROLENE ARE SUPPORTING THE EXPANSION FORCES. THE IN VIVO EXPANSION FORCES ARE ESTIMATED TO BE LESS THAN 9 N (2 LBF) THEREFORE IT IS HIGHLY UNLIKELY THAT THE PROLENE SUTURES BROKE. IT IS MOST LIKELY THAT THE KNOTS IN THE PROLENE SUTURES CAME UNTIED EARLY IN THE POST-OPERATIVE COURSE OF THE PATIENT, BEFORE COMPLETE ENDOTHELIALIZATION OF THE DEHISCED REGION OF THE DEVICE COULD OCCUR. SERIAL ECHOCARDIOGRAMS PROVIDE SOME EVIDENCE OF EARLY SEPARATION OF THE DEVICE FROM THE ANNULUS. THESE FINDINGS SUPPORT THE THEORY OF AN EARLY UNTYING OF THE SUTURE KNOTS. THE PATIENT WAS IMPLANTED IN 2013 DURING A PRE-MARKET CLINICAL TRIAL. A REVISED TECHNIQUE FOR SUTURE MANAGEMENT (LATERAL SUTURE FIXATION) WAS IMPLEMENTED PRIOR TO COMMERCIALIZATION OF THE DEVICE IN 2016. WITH THIS METHODS, THE PROLENE KNOTS ARE TIED TIGHTLY WITH 8 KNOTS, THE SUTURE IS PASSED DOWNWARD THROUGH THE LATERAL PLEDGET, AND THE SUTURE IS TIED AGAIN WITH 6 MORE KNOTS. THE REVISED TECHNIQUE IS INTENDED TO PREVENT SUTURE KNOTS FROM COMING UNTIED AND ASSURING KNOT TOWERS ARE TIED DOWN TO PREVENT ABRASION.

D

Patient 1

PATIENT WITH RECURRENT INSUFFICIENCY WAS OPERATED ON (B)(6)2017 TO REMOVE HAART 300 DEVICE. THE DEVICE WAS SEPARATED FROM THE ANNULUS NEAR THE RIGHT CORONARY CUSP.