MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC VENOVO STENT 14MMX140; STENT, ILIAC VEIN

Model Number VENUL14140

Device Problem Mechanical Problem (1384)

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

Event Date 11/18/2020

Event Type  malfunction  

Event Description

Physician went to deploy a 14mmx140mm venovo venous stent.During deployment, the stent failed to release from the catheter completely.After manipulation, the stent released with no harm to the patient.Fda safety report id # (b)(4).

• Brand Name: VENOVO STENT 14MMX140
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC
• MDR Report Key: 10902979
• MDR Text Key: 218704619
• Report Number: MW5098062
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VENUL14140
• Device Catalogue Number: VENUL14140
• Device Lot Number: ANEV0604
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 78 YR