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

Model Number 428

Device Problem Misassembled (1398)

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

Event Date 09/02/2019

Event Type  malfunction  

Manufacturer Narrative

The production traveler (device history record) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There are no other associated complaints with this lot of devices.The device was sent to the foreign distributor/user with coarctation of the aorta labeling and ifu.At that time, the rvot indication for which this device was used, was not approved in the eu.The device has since received approval for that indication.All numed devices are 100% final inspected before release.This process includes a full final inspection on the both the catheter and stent before the mounting process has been performed.There is an additional inspection performed after the stent has been pre-mounted on the balloon catheter.There were no issues found with this device during the inspection.The cmcp device was returned to numed for review.The 14fr mullins introducer that was used on this device was not returned to numed for review, so we are unable to determine if that introducer measured appropriately.The cmcp was returned in its box and a plastic bag.The stent has been removed from the bib.There is a 14fr hemostasis valve tool on the bib's shaft.All four adhesive spots are attached on the covered cp stent.One end of the stent has been flattened and the zigs are overlapped (picture ccn-915 stent).The od of the other end is 0.134" folds are still present in the bib's outer balloon.The area where the stent was mounted on the balloon is still visible (picture ccn-915 bib).The stent was recrimped on the bib following standard procedures.The stent was passed through a 14fr d'vill introducer using the hemostasis valve tool that was on the catheter.The stent easily passed through the introducer with no dislodgement.Numed could not re-create the complaint.

Event Description

As per the report from the foreign user facility and distributor - covered mounted cp stent 39ccps on 22mm bib.Initial inspection concerned stent not mounted on balloon appropriately, further crimping performed.14fr mullins protector used for haemostatic valve, stent moved proximally off of balloon.Removed from patient.Procedure carried out using a different nudel system.No concern.Stenting previous surgical pulmonary valve replacement and subsequent percutaneous pulmonary valve implantation.

• Brand Name: COVERED MOUNTED CP STENT
• Type of Device: AORTIC STENT SYSTEM
• 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: 9193247
• MDR Text Key: 196223979
• Report Number: 1318694-2019-00022
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 10/15/2019

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: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 428
• Device Catalogue Number: CMCP021
• Device Lot Number: CMCP-1272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 28 YR
• Patient Weight: 60