FDA.reportPublic FDA data

MAUDE MDR 6826600

MDR report key
6826600
Report number
1318694-2017-00025
Event key
0
Event type
3
Date of event
2017-08-15
Date received
2017-08-29
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
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.PNF427CVRDCP8Z34CCP-0660Y R

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-290

Event Narratives#

N

Patient 1

THE STENT WAS RETURNED AND EVALUATED. THE STENT HAD BEEN CRIMPED DOWN SO SMALL THAT THE ZIGS AT THE END OF THE STENT ARE OVERLAPPED (SEE PICTURE ATTACHMENTS). ONE GLUE SPOT WAS DETACHED. THERE ARE WEAK SPOTS IN THE COVERING THAT APPEAR TO HAVE BEEN CAUSED WHEN THE COVERING WAS PINCHED BETWEEN THE STRUTS DURING CRIMPING. THIS STENT IS ONLY APPROVED TO BE USED ON 12MM - 24MM BALLOONS. ANYTHING SMALLER THAN THAT CAN DAMAGE THE STENT. IT IS LIKELY THAT THE CRIMPING OF THE STENT DOWN ON SUCH A SMALL BALLOON LED TO THE WEAK SPOTS IN THE COVERING. A WARNING IN THE INSTRUCTIONS FOR USE STATES :"CRIMPING THE STENT ON A BALLOON CATHETER SMALLER THAN 12MM MAY CAUSE DAMAGE TO THE STENT."

D

Patient 1

AS PER THE REPORT FROM BIS - "PHYSICIAN WAS CRIMPING THE STENT ON THE BALLOON. AFTER CRIMPING, PHYSICIAN NOTICED WHAT APPEARED TO BE SOME TEARS IN THE MATERIAL THAT WERE NOT BELIEVED TO BE CAUSED BY THE PHYSICIAN. THE STENT WAS REMOVED AND ANOTHER STENT PLACED. THE STENT WAS BEING MOUNTED ON A 10X3.5 BIB. THERE WAS NO DIFFICULTY MOUNTING THE STENT. CRIMPING WAS DONE BY HAND. THE RING MANDRIL WAS NOT USED DURING CRIMPING. THE STENT DID NOT SLIP. THE SLIGHT TEARS IN THE COVERING OF THE STENT WERE NOT BELIEVED TO BE CAUSED BY THE CRIMPING PROCESS. CONTRAST WAS BEING USED DURING PREP. PHYSICIAN WAS USING THE PRODUCT FOR SEVERE COARCTATION OF AORTA."