FDA.reportPublic FDA data

MAUDE MDR 7483641

MDR report key
7483641
Report number
1318694-2018-00005
Event key
0
Event type
3
Date of event
2018-03-19
Date received
2018-05-03
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
MS. NICHELLE LAFLESH
Address
2880 MAIN STREET HOPKINTON NY 12965 US
Phone
315-315-3153
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COVERED CP STENTAORTIC STENTNUMED, INC.PNF427CVRDCP8Z45CCP-0611R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-05-030

Event Narratives#

N

Patient 1

THE COVERED CP STENT WAS NOT RETURNED TO NUMED, SO THE MALFUNCTION COULD NOT BE CONFIRMED. ONE STENT FROM THE LOT WAS PULLED AND TESTED FOR COVERING STRENGTH BEFORE THE LOT WAS RELEASED FOR DISTRIBUTION. THE STENT MET ALL CRITERIA FOR COVERING STRENGTH AS PER THE SPECIFICATION.

D

Patient 1

AS PER THE REPORT FROM THE PHYSICIAN AND DISTRIBUTOR - "THE PTFE WAS DETACHED FROM THE CP WHEN THE PHYSICIAN TOOK IT. IT HAPPENED BEFORE THE PROCEDURE."