MAUDE Adverse Event Report: NUMED, INC. COVERED CP STENT; AORTIC STENT

Model Number 427

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/26/2018

Event Type  malfunction  

Manufacturer Narrative

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.

Event Description

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.".

• Brand Name: COVERED CP STENT
• Type of Device: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton NY 12965
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, NY 12965 ; 3153284491
• MDR Report Key: 8282442
• MDR Text Key: 136744571
• Report Number: 1318694-2019-00002
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/28/2023
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0854
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 50