COVERED CP STENT 427 CVRDCP8Z28

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-12-15 for COVERED CP STENT 427 CVRDCP8Z28 manufactured by Numed, Inc..

Event Text Entries

[62801852] The detached covering has been confirmed. The covering is undamaged and four glue spots are visible on the covering. The od of the stent is 0. 167". The stents have an od of 0. 181 when shipped from numed. It appears the covering became detached when the physician attempted to remove it from the sheath to re-crimp the stent. A special tool needs to be used to insert the stent through the hemostasis valve, so that the cover will not catch. When pulling back through the hemostasis valve, the covering will catch and detach from the stent. The od of the stent was 0. 167" which is very close to the od of the stent when shipped from numed. It is likely that the stent shifted because it was not fully crimped on the balloon. This indirectly led to the covering issue since it had to be removed back through the hemostasis valve in order to re-crimp the stent on the balloon. The instructions for use states that the stent should be crimped until no movement is felt on the catheter. It also states to place a small amount of undiluted contrast to coat the stent and improve adherence to the balloon. Numed is unable to confirm whether or not this was followed. The distributor has stated that no other information is available.
Patient Sequence No: 1, Text Type: N, H10


[62801853] As per the report from the distributor: "during delivery, stent was found to have shifted on the bib. Then the physician tried to re-crimp the stent, the cover fell off. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1318694-2016-00014
MDR Report Key6177128
Date Received2016-12-15
Date of Report2016-12-15
Date of Event2016-08-17
Date Mfgr Received2016-11-28
Device Manufacturer Date2015-05-19
Date Added to Maude2016-12-15
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMS. NICHELLE LAFLESH
Manufacturer Street2880 MAIN STREET
Manufacturer CityHOPKINTON NY 12965
Manufacturer CountryUS
Manufacturer Postal12965
Manufacturer Phone3153284491
Manufacturer G1NUMED, INC.
Manufacturer Street2880 MAIN STREET
Manufacturer CityHOPKINTON NY 12965
Manufacturer CountryUS
Manufacturer Postal Code12965
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameCOVERED CP STENT
Generic NameAORTIC STENT
Product CodePNF
Date Received2016-12-15
Returned To Mfg2016-12-01
Model Number427
Catalog NumberCVRDCP8Z28
Lot NumberCCP-0592
OperatorPHYSICIAN
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerNUMED, INC.
Manufacturer Address2880 MAIN STREET HOPKINTON NY 12965 US 12965


Patients

Patient NumberTreatmentOutcomeDate
10 2016-12-15

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