FDA.reportPublic FDA data

MAUDE MDR 1366097

MDR report key
1366097
Report number
3007456607-2009-00002
Event key
0
Event type
3
Date of event
2009-02-20
Date received
2009-03-20
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 RD 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, LLCDQXOP3015OP30152009-08-29Y Y

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12009-03-2001. O

Event Narratives#

D

Patient 1

DURING OSTIAL STENTING OF AN UPLM ONE OF THE FOUR OSTIAL PRO LEGS BROKE OFF FROM THE CYLINDER WHILE ALIGNING THE LEGS OF THE OSTIAL PRO WITH THE OSTIUM OF THE LEFT MAIN ARTERY. THE LEG MIGRATED DISTALLY AND SETTLED IN A SMALL BRANCH OF THE PROFUNDUS OF THE RIGHT LEG. NO ATTEMPT WAS MADE TO RETRIEVE THE LEG AS THE PHYSICIAN FELT IT HAD SAFELY EMBOLIZED AND WOULD BE QUICKLY ENDOTHELIALIZED. PROCEDURE WAS COMPLETED, PATIENT IS FINE AND NO OTHER COMPLICATIONS REPORTED.

N

Patient 1

CONCLUSION: THE BRITTLE LEG FAILURE IS CONSIDERED AN ISOLATED OCCURRENCE SINCE OTHER PRODUCTS FROM THE SAME LOT OF PRODUCT DID NOT SHOW ANY SIGNS OF BRITTLENESS. HOWEVER, MOVING FORWARD, A 100% INSPECTION OF ALL PRODUCTION UNITS WILL BE TESTED TO ASSURE THAT PRODUCT LOTS REMAIN BRITTLE FREE.