COVERED CP STENT 427 CVRDCP8Z45

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-01-28 for COVERED CP STENT 427 CVRDCP8Z45 manufactured by Numed, Inc..

Event Text Entries

[136744571] The stent was returned in its box, pouch and vial. The covering is completely detached, but is completely intact and undamaged. Four adhesive spots are visible on the covering. A visual examination of the stents shows that the stent was crimped down. The od of the stent is 0. 145". The od of stents is 0. 181" when shipped. The zigs of the complaint stent are also overlapped. The complaint is confirmed, however it appears that the detachment occurred after the stent had been crimped down. A picture is attached that shows the complaint stent next to a stent that was removed from its packaging without being altered. One sample from every lot is tested for adhesion strength of the covering to the stent. The sample from this lot met the acceptance criteria.
Patient Sequence No: 1, Text Type: N, H10


[136744572] As per the report from the physician / user facility - "after removing the cover stent from the package, it turned out that the eptfe was not attached to stent. The stent was not implanted. "
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1318694-2019-00002
MDR Report Key8282442
Date Received2019-01-28
Date of Report2019-01-28
Date of Event2018-11-26
Date Mfgr Received2019-01-03
Device Manufacturer Date2018-01-30
Date Added to Maude2019-01-28
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 Received2019-01-28
Returned To Mfg2019-01-11
Model Number427
Catalog NumberCVRDCP8Z45
Lot NumberCCP-0854
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 2019-01-28

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