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

Model Number 427

Device Problem Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/14/2021

Event Type  Injury  

Event Description

As per the report from the (b)(6) distributor / user facility.On (b)(6) 2021 the ccp: (b)(4), lot : ccp-0772, per: (b)(4).Is placed for a premelody.No problems or comments at this time.On (b)(6) 2021 melody valve implantation.Visible on endoscopy that strut was loose.When using the mt catheter, the loose piece of the cp stent came loose and got stuck in the sinus coronarius.Position was stable, so they decided to place melody valve first and then recover the piece of the stent.

Manufacturer Narrative

A piece fractured off of the covered cp stent and was removed surgically.The rest of the stent remained implanted in the patient.The piece of stent was returned to numed for evaluation.The fragment consists of 3 zigs, four struts failed.The fractured struts were examined at 10x magnification.The ends of the broken struts are clean with no jagged edges.A sample stent from each lot is tested for weld strength (5 welds).The sample from this lot of stents had an average weld strength of 15.59lbf, which is well 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.A review was performed on the component lots used for the manufacturing of this lot of devices.There were no other associated complaints with the components used.Additional information was received from the foreign distributor / physician.It was stated that the physicians believe that the strut failures were due to the "strength of the own pulmonary ring" in the patient.

• 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: 13236439
• MDR Text Key: 283949790
• Report Number: 1318694-2022-00001
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 03/31/2022
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-0772
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2021
• Initial Date FDA Received: 01/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2017
• 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 Outcome(s): Required Intervention