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

Model Number 427.1

Device Problem Device Handling Problem (3265)

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

Event Date 06/24/2022

Event Type  malfunction  

Event Description

As per the initial report from the foreign distributor / user facility - "all the stent the outer cover was floppy and easily peelable.Hence we had difficulty as the outer cover would move and the stent worked as bare stent.The mounted stent too the balloon was already crimped ie looked like used ballon on which this stent was mounted was reused.Definitely not a premounted stent." unmounted covered cp stents had covering issues according to this user facility.Will be reported with 1318694-2022-00008.Both devices were used on the same patient during the same procedure.A covered mounted stent was then used with no reported issues with the covering.

Manufacturer Narrative

The complaint stent was not returned so the complaint could not be confirmed and an investigation of the complaint device itself could not be performed.The stent was implanted as a bare stent.All covered cp stents are inspected for proper covering attachment in final inspection.A sample from each lot is tested for covering strength.The sample from this lot failed at 2.64lbs, well above the 1.5lb minimum.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 or with the components used on the devices.According to the report sent by the user facility, this device was being used off label for an unapproved indication.The physician listed on the patient record is performing procedures through a fellowship.Based on information from the physician / user facility the covering came off in the introducer, which is typically related to the physician not following the instructions for use by using the supplied tools to defeat the hemostasis valve.It is also unknown as to what size and type of catheter was used for this procedure.If the balloon catheter used was too small, the stent would have been crimped down below it's rated size makeing the stent zigs overlap where the adhesive spots are located.Additional information was requested, but none was received.

• 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: 15110874
• MDR Text Key: 302191611
• Report Number: 1318694-2022-00009
• Device Sequence Number: 1
• Product Code: PNF
• UDI-Device Identifier: 04046955195190
• UDI-Public: 04046955195190
• 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: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/27/2022

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 Model Number: 427.1
• Device Catalogue Number: CVRDCP8Z60
• Device Lot Number: CCP-1713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/05/2022
• Initial Date FDA Received: 07/27/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/28/2022
• 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: 26 YR
• Patient Sex: Female