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

Model Number 427

Device Problems Defective Device (2588); Material Deformation (2976)

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

Event Date 05/07/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation.The covering is completely in tact with no issues.All four glue spots are attached and there was nothing wrong with it.The distal end of the stent had one zig that was bent out (see attached pictures - 835 complaint stent and 835 complaint stent2).Numed pulled a comparative stent to try and similate the bend in the zig like the complaint stent.When sliding the stent on a balloon catheter, when the balloon did not have a vacuum on it, the stent caught on the balloon during the advancement and ended up with similar damage to one of the zigs (see attached pictures - 835 comparative1 and 835 comparative2).Numed fully inspects all zigs on each stent before it is placed in a bottle for packaging.The bent zig had to had occurred at the user facility.Similar damage was observed while forcing a stent over a balloon that had not been properly prepped, making improper handling the most likely cause of the complaint.(b)(4).

Event Description

As received by the distributor in turkey - "before the coarctation of the aorta case of the patient, the covered cp stent was checked and it was observed that the proximal of the distal ends of the stent were deformed and there were defects on the covered parts of the stent.".

• 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: 7557760
• MDR Text Key: 109898350
• Report Number: 1318694-2018-00007
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 11/30/2022
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/20/2017
• 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: 21 YR
• Patient Weight: 87