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

Model Number 428

Device Problem Separation Failure (2547)

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

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

The complaint stent, bib and ring mandril were returned in separate (b)(6) bags.All of the returned components are clean and free of blood.The covering is detached and was not returned.The adhesive spots are visible on the stent.The stent has been slightly flattened.The catheter was returned with (2) 0.015 mandrils in the guidewire lumen.There is no blood on the catheter and no contrast in the balloon.The balloon has very well defined folds.The condition of the stent and the bib leads us to believe that they never entered he introducer.The stent and catheter are both completely free of blood and the balloon still has well defined folds that would not be present if the "poba" had occurred.At this time it is impossible to determine the actual nature of the complaint, which makes it impossible to determine the root cause.(b)(4).

Event Description

As reported to numed - "in the first instance we were able to do 'poba' only as the stent remained in the sheath itself.".

• Brand Name: COVERED MOUNTED 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: 8282446
• MDR Text Key: 135522669
• Report Number: 1318694-2019-00004
• 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: 10/31/2022
• Device Model Number: 428
• Device Catalogue Number: CMCP025
• Device Lot Number: CMCP-1756
• 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: 10/17/2017
• 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