MAUDE Adverse Event Report: BARD LIFE STENT XL VASCULAR AND BILLIARY STENT; VASCULAR STENT

Catalog Number EX07100CS

Device Problem Break (1069)

Patient Problems Pain (1994); Vascular System (Circulation), Impaired (2572)

Event Date 06/10/2013

Event Type  Injury  

Event Description

On (b)(6) 2013 admitted for emergency surgery, blood clot collapsed artery, 5 stents put in.Between (b)(6) 2013 and (b)(6) 2015, needed arterial transplant and graft - (b)(6) 2015.On (b)(6) 2013 i went to mgh for a pain in my right leg.After a cat scan, i was admitted for emergency surgery for a collapsed artery and blood clot.They put in 5 stents from my knee to my groin.Somehow between then and (b)(6) 2015 after ensuring indescribable pain i went back to mgh.I was admitted again, because they told me one of the stents broke after a cat scan.I could lose my leg.I didn't have emergency surgery once again, so they did an arterial transplant and graph, while heaving said 5 stents still implanted in my leg leaving a two and a half foot scar from my ankle to my waist.I could have lost my leg.

• Brand Name: LIFE STENT XL VASCULAR AND BILLIARY STENT
• Type of Device: VASCULAR STENT
• Manufacturer (Section D): BARD
• MDR Report Key: 5566866
• MDR Text Key: 42419253
• Report Number: MW5061586
• Device Sequence Number: 1
• Product Code: NIO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/01/2014
• Device Catalogue Number: EX07100CS
• Device Lot Number: #ANWC3738
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 79