FDA.reportPublic FDA data

MAUDE MDR 1476716

MDR report key
1476716
Report number
3007456607-2009-00004
Event key
0
Event type
3
Date of event
2009-05-27
Date received
2009-06-26
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#

Address
1111 SHORT ROAD KALAMAZOO MI 49008 US
Phone
866-866-8668
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1OSTIAL PRO STENT POSITIONING SYSTEMDQX WIRE, GUIDE CATHETEROSTIAL SOLUTIONS LLCDQXOP3015OP30152009-09-05Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-06-2601. O

Event Narratives#

D

Patient 1

IT WAS REPORTED DURING THE STENTING OF THE LEFT RENAL ARTERY ONE OF THE FOUR OSTIAL PRO LEGS BECAME DETACHED FROM THE CYLINDER BODY AND MIGRATED DISTALLY INTO THE PERIPHERAL VASCULAR BED. ATTEMPTS TO RETRIEVE THE DETACHED LEG WERE UNSUCCESSFUL. THE CASE WAS SUCCESSFULLY COMPLETED USING THE REMAINING THREE LEGS OF THE OSTIAL PRO TO ACCURATELY PLACE THE STENT. PT IS FINE. NO FURTHER COMPLICATIONS TO REPORT.

N

Patient 1

THIS IS THE 2ND LEG FAILURE THAT HAS OCCURRED ON THE OSTIAL PRO AND THE 1ST ON LOT # 2009-09-05. THE LEG BRITTLENESS IS SUSPECTED TO BE THE RESULT OF HYDROGEN EMBRITTLEMENT, WHICH CAN POTENTIALLY BE INTRODUCED THROUGH THE ELECTROPOLISHING AND ELECTROPLATING STEPS IN THE MANUFACTURING PROCESS. CURRENTLY, AN ONGOING INVESTIGATION OF THE LEG BRITTLENESS ISSUE IS TAKING PLACE. ALL LOTS PRODUCED SINCE THIS DEFECT WAS IDENTIFIED, HAVE BEEN 100% INSPECTED (FATIGUE TESTED) TO IDENTIFY BRITTLE PARTS.