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

Model Number 427

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Failure of Implant (1924)

Event Date 06/28/2019

Event Type  malfunction  

Manufacturer Narrative

The stent and hemostasis valve tools were returned in the original pouch and vial.The covering is completely detached.There is blood on the covering.Four adhesive spots are visible on the covering.The stent has been crimped down, and the od of the stent is 0.133" the hemostasis valve tools are undamaged.The device history records were reviewed, and no issues were found.One device from every lot is tested for covering strength as part of the final inspection process.For lot number ccp-1046, the covering strength was 3.19008 which is above the acceptance criteria of: greater than 1.5 lbs.The root cause of the detachment cannot be determined.

Event Description

Description of event as sent to numed by the distributor on the incident report - after stent was fully crimped and visually inspected, the physician inserted mounted covered cp stent into the appropriate tool.During this procedure, the physician observed that the ptfe on the stent was peel off while it was inserted the long sheath.The physician pulled out the covered mounted stent from the patient and used another stent.Another cvrd stent was implanted successfully.The patient discharged from the hospital.

• 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: 8826313
• MDR Text Key: 190801247
• Report Number: 1318694-2019-00016
• Device Sequence Number: 1
• Product Code: PNF
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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: 07/25/2019

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: 03/31/2024
• Device Model Number: 427
• Device Catalogue Number: CVRDCP8Z45
• Device Lot Number: CCP-1046
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/19/2019
• 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
• Patient Age: 17 YR
• Patient Weight: 60