FDA.reportPublic FDA data

MAUDE MDR 6399421

MDR report key
6399421
Report number
1318694-2017-00008
Event key
0
Event type
3
Date received
2017-03-13
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
MS. NICHELLE LAFLESH
Address
2880 MAIN STREET HOPKINTON NY 12965 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1COVERED CP STENTAORTIC STENTNUMED, INC.PNF427CVRDCP8Z45CCP-0688Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-03-130

Event Narratives#

N

Patient 1

THE STENT WAS RETURNED BLOODY AND IN A (B)(4) BAG. TWO GLUE SPOTS ARE DETACHED, AND THE COVERING IS TORN. THE TEAR STARTS AT ONE OF THE GLUE SPOTS AND EXTENDS TO THE MIDDLE OF THE STENT. ONE END OF THE STENT HAS BEEN CRUSHED UNTIL IT IS ALMOST COMPLETELY FLAT. THIS IS THE END WHERE THE DETACHMENT OF THE COVERING OCCURRED. IT IS PROBABLY THAT THE COVERING DETACHED WHEN THE STENT WAS CRUSHED DURING THE CRIMPING PROCESS. AN IMPROPER CRIMPING TECHNIQUE WAS BEING USED. NUMED HAS BOTH MOUNTING VIDEOS FOR PHYSICIANS SHOWING THEM THE PROPER TECHNIQUE FOR CRIMPING THE STENT, AS WELL AS STEP BY STEP PICTORIALS THAT ARE SENT WITH EACH STENT THAT IS NOT PRE-MOUNTED BY NUMED. THE MOUNTING PROCESS WAS NOT FOLLOWED BY THE PHYSICIAN.

D

Patient 1

AS PER THE REPORT FROM THE FOREIGN DISTRIBUTOR: "THE CUSTOMER IS COMPLAINING THAT THE COATING DISSOLVED DURING CRIMPING." THIS MEANS THAT THE COVERING DETACHED DURING THE CRIMPING PROCESS.