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

Model Number 427

Device Problems Device Damaged by Another Device (2915); Torn Material (3024)

Patient Problem No Information (3190)

Event Date 04/13/2018

Event Type  malfunction  

Manufacturer Narrative

The device was returned in a biohazardous condition.Proper precautions were taken in the handling of the device for the evaluation.The stent has been crimped, but was not crimped evenly along the device.Two adhesive spots were detached and two were still attached.All four can be confirmed as having been there.One sample from each lot is tested for covering strength.The sample from this lot met the required pull strength for release of the lot.One end of the covering has been torn and pushed back approximately half the length of the stent.This is seen when the device is inserted into a hemostasis valve of an introducer without the use of the hemostasis tools provided with the covered stent.The device is shipped with both an instructions for use that states the necessary steps for inserting into the hemostasis valve as well as an ifu insert that provides written as well as a pictorial presentation of the steps for mounting and inserting the covered stent.These instructions were not followed in this case.The tearing of the covering was due to user handling as well as failure to follow instructions.(b)(4).

Event Description

As per the report from the hospital and distributor - "the covered layer torn mounting the stent on the balloon.".

• 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: 7511464
• MDR Text Key: 108732507
• Report Number: 1318694-2018-00006
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 01/31/2022
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0752
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2017
• 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