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

Model Number 425

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Information (3190)

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint stent was returned in its box and outer pouch.There is no blood on the stent and there is no evidence that the stent entered the body.The stent is deformed and appears to have been partially expanded.The length of the stent is approximately 3.7 cm.The foreshortening chart in the ifu shows that an 8 zig, 3.9 cm cp stent would have to be inflated to 12 or 14mm to reach this length.It is impossible to determine when, where, how or why they stent slipped off of the bib without more information, however, it is likely that the dislodgement was caused by one of the following: the hemostasis valve tool was not used to properly defeat the hemostasis valve in the introducer, or the stent was not securely crimped down on the balloon.The following statements are in the instructions for use - "gently crimp (see insert ifu-cpce) the stent on the balloon by using finger pressure and a "rolling action" to exert equal pressure on all sides of the stent.Only crimp until no movement is felt on the catheter.Platinum is very malleable and should be easily crimped.Place a small amount of undiluted contrast to "coat" the stent and improve adherence to the balloon.(avoid bending or twisting the stent)." the ifu-cpce (mounting instructions sent with the instructions for use) also contains information about the use of the hemostasis valve tools to defeat the hemostasis valve on the introducer.

Event Description

As reported from the hospital - "stent slipped off the balloon (bib balloon catheter) while traversing through the femoral vascular sheath and had to be snared out with damaged struts through goose neck snare.".

• Brand Name: 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: 8282449
• MDR Text Key: 136610435
• Report Number: 1318694-2019-00003
• 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,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/28/2019

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: No Information
• Device Expiration Date: 08/31/2022
• Device Model Number: 425
• Device Catalogue Number: CP8Z39
• Device Lot Number: CP-0861
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2019
• Initial Date FDA Received: 01/28/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13 YR
• Patient Weight: 25