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

Model Number 427.1

Device Problem Material Separation (1562)

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

Event Date 06/21/2023

Event Type  malfunction  

Manufacturer Narrative

The stent was returned in a bag along with its outer pouch.The covering and stent are clean.All four adhseive spots are detached.All glue spots are visible.The ends of the stent have been crimped down.The ods at the end of the stent measured 0.138" and 0.131".The zigs at each end of the stent are overlapped.All covered 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 2.60 lbs, which is well above the 1.5 lb minimum required.The production traveler (dhr) was reviewed and no issues were found.All devices in this lot met the criteria for release and distribution.There have been no other complaints for this lot of devices.

Event Description

As per a report from the user facility and foreign distributor - a 4.5cm covered cp stent ws mounted on a 20mm/4.5cm bib catheter, and the stent-balloon comple was introduced into the 14fr d'vill long sheath with the standard introducer that comes with the covered cp stent.During advancement of the stent-balloon complex in the long sheath, the stent was found to have slipped proximally on the balloon catheter and hence the whole system including the bib catheter, the long sheath and together with the covered stent were retrieved with the guidewire position maintained.The covered stent was noted to have lodged in the middle of the long sheath by fluoroscopy.However, the ptfe membrane of the covered cp stent and the cp stent were found to be separated when the stent was flushed out of the long sheath (with gentle saline injection via the side-arm of the long sheath).The ptfe membrane of the covered stent was found detached completely from the cp stent.Both the stent and the ptfe membrane were intact.There was no material found left in the patient.The intended procedure of covered stent implantation was completed using a new 4.5cm covered cp stent mounted on the same 20mm/4.5cm bib catheter and delivered via the same d'vill long sheath.

• 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: 17336820
• MDR Text Key: 319440607
• Report Number: 1318694-2023-00006
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: P150028
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2023

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: CVRDCP8Z45
• Device Lot Number: CCP-1131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2023
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2019
• 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