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

Model Number 427

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 07/31/2017

Event Type  malfunction  

Manufacturer Narrative

The covering detachment is confirmed.The stent has been crimped down, even though the report states that this happened prior to crimping.The od of the stet is 0.150".The stents are shipped with an od of 0.181".Sever overlapping of the zigs at the ends of the stent were observed (see attached photos).One of the zigs has been manipulated in a way that left it completely turned over.Upon examination of the stent it has been determined that the detachment was most likely caused by mishandling of the stent either during crimping or before crimping.The od of the returned stent was well below the od of stents when they are shipped.The ends of the stent were overlapped and deformed.All covered stents are inspected in final qc to insure each covering has (4) acceptable glue spots.The stent are visually inspected once more after they are packaged for covering adhesion.A sample from each lot is tested for covering strength.The sample from this lot failed at 2.82lbs, well above the 1.5lb minimum.

Event Description

As per the incident report from the distributor - "covering material outside cp stent was damaged prior to crimping hence was not used for deployment.".

• 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: 6803436
• MDR Text Key: 83311170
• Report Number: 1318694-2017-00023
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2020
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z34
• Device Lot Number: CCP-0597
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/02/2017
• Initial Date FDA Received: 08/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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: 20 YR