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

Model Number 425

Device Problem Fracture (1260)

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

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

The stent has not been returned to numed for evaluation.It remains implanted in the patient.A sample stent from each lot is tested for weld strength (5 welds).The sample from this lot of stent had an average weld strength of 15.22lbf, which is above the minimum specification.The production traveler (dhr) 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.As per the report from the user facility / distributor, this stent was implanted in an unapproved location for an unapproved indication.The bare cp stent is only indicated for coarctation of the aorta.The complaint was sent to a consultant physician for review and these were his comments: " the stent was placed between sternum and aorta; with every heartbeat it is squished between these; i presume that at the end of placing the stent, there was significant motion of the stent.It is a general rule that every metal that moves will develop metal fatigue and will eventually fracture.In order to avoid that once must add strength (=additional stents) until no more motion.Metal that does not move will not fracture.".

Event Description

Stent fracture of a bare cp stent placed in 2018.

• Brand Name: CP STENT
• Type of Device: AORTIC STENT
• Manufacturer (Section D): NUMED, INC.; 2880 main street; hopkinton, ny
• Manufacturer (Section G): NUMED, INC.; 2880 main street; hopkinton, ny
• Manufacturer Contact: nichelle laflesh ; 2880 main street; hopkinton, ny ; 3284491
• MDR Report Key: 9786127
• MDR Text Key: 190799780
• Report Number: 1318694-2020-00005
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: TW
• 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: 03/04/2020

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: 05/31/2023
• Device Model Number: 425
• Device Catalogue Number: CP8Z28
• Device Lot Number: CP-0942
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/19/2020
• Initial Date FDA Received: 03/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/02/2018
• 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
• Patient Age: 14 YR
• Patient Weight: 85