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

Model Number 427

Device Problems Detachment Of Device Component (1104); Malposition of Device (2616)

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

Event Date 05/23/2016

Event Type  malfunction  

Manufacturer Narrative

The detached covering has been confirmed.The covering is undamaged and four glue spots are visible on the covering.The od of the stent is 0.178".The stents have an od of 0.181 when shipped from numed.It appears the covering became detached when the physician attempted to remove it from the sheath to re-crimp the stent.A special tool needs to be used to insert the stent through the hemostasis valve, so that the cover will not catch.When pulling back through the hemostasis valve, the covering will catch and detach from the stent.The od of the stent was 0.178" which is very close to the od of the stent when shipped from numed.It is likely that the stent shifted because it was not fully crimped on the balloon.This indirectly led to the covering issue since it had to be removed back through the hemostasis valve in order to re-crimp the stent on the balloon.The instructions for use states that the stent should be crimped until no movement is felt on the catheter.It also states to place a small amount of undiluted contrast to coat the stent and improve adherence to the balloon.Numed is unable to confirm whether or not this was followed.The distributor has stated that no other information is available.

Event Description

As per the report from the distributor: "during delivery, the stent was noticed to be shifted from the balloon.When the physician tried to withdraw the system to reposition the stent, the cover fell off.".

• 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: 6177165
• MDR Text Key: 62703845
• Report Number: 1318694-2016-00015
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046964898914
• UDI-Public: 04046964898914
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 12/15/2016

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: 01/31/2019
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z39
• Device Lot Number: CCP-0514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/28/2016
• Initial Date FDA Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 42 YR
• Patient Weight: 72