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

Device Problems Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem Insufficient Information (4580)

Event Date 03/10/2021

Event Type  Injury  

Event Description

Venous stent failed to fully deploy and delivery system shaft was stuck to under expanded stent in "candy wrapper" configuration.It took 15min of shaft manipulation and eventually the stent fully expanded.This is in line with the field safety notice issued by company, particularly with the 14mm diameter venovo stents.Fda safety report id # (b)(4).

• Brand Name: VENOVO 14MM
• Type of Device: STENT, ILIAC VEIN
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC
• MDR Report Key: 11482743
• MDR Text Key: 240284280
• Report Number: MW5099988
• Device Sequence Number: 1
• Product Code: QAN
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2021

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/12/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 91 YR