FDA.reportPublic FDA data

MAUDE MDR 891593

MDR report key
891593
Report number
2916596-2007-00122
Event key
0
Event type
3
Date of event
2007-07-13
Date received
2007-08-09
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
ROBERT FRYC
Address
6035 STONERIDGE DR. PLEASANTON CA 94588 US
Phone
925-925-9258
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HEARTMATE APICAL SEWING RINGVAD APICAL SEWING RINGTHORATEC CORP.DSQ1065106560905NNR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12007-08-0901. R

Event Narratives#

D

Patient 1

DURING IMPLANT OF ONE PATIENT WITH THE MANUFACTURER'S CLINICAL TRIAL LVAD, THE SURGEON STATED THAT THE FELT ON THE APICAL SEWING RING CLOSEST TO SILICONE TUBE WAS LOOSE, BUT THE SUTURE HOLDING THE FELT TO SILICONE TUBE WAS INTACT. HE ALSO STATED HE HAD OBSERVED THE SAME ISSUE DURING ANOTHER PATIENT'S CLINICAL TRIAL IMPLANT TWO DAYS BEFORE. THE SURGEON STATED THAT THERE WAS A POTENTIAL FOR INCREASED INCIDENCE OF BLEEDING REQUIRING THE ADMINISTRATION OF BIO-GLUE TO THE LOOSE FELT ON BOTH PATIENTS AS A PRECAUTION. ONE PATIENT WAS SUBSEQUENTLY TRANSPLANTED AND THE OTHER REMAINS ONGOING WITH NO FURTHER ISSUES. SINCE NEITHER SEWING RING WAS AVAILABLE FOR ANALYSIS THE SURGEON WAS SENT ADDITIONAL STERILE SEWING RINGS FOR HIS REVIEW AND RETURNED ONE SEWING RING THAT HE BELIEVED HAD SIMILAR ISSUES FOR EVALUATION BY THE MANUFACTURER.

N

Patient 1

NEITHER IMPLANTED SEWING RING WAS RETURNED FOR EVALUATION; HOWEVER, THE SURGEON SENT IN A THIRD UNUSED SEWING RING, WHICH HE BELIEVED HAD THE SAME ISSUE. THE RETURNED UNUSED SEWING RING IS CURRENTLY BEING INVESTIGATED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME.