MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. LIFESTREAM COVERED STENTS X2; ILIAC COVERED STENT, ARTERIAL

Model Number LIFESTREAM 7MMX 37MM

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/23/2021

Event Type  Injury  

Event Description

Bard lifestream 6 mm x 26 mm stent (ref# lsmu1350626, lot# cmdn0297) placed on guidewire to go in to be deployed in sma, stent came off balloon before entering body without being deployed.New lifestream 7 mm x 37 mm stent (ref# lsmu1350737, lot# cmfr0263) given by vendor, prep and delivery into body supervised by vendor and all actions per vendor recommendations.After 2nd stent in body, stent came off balloon in patient artery not where it was intended to be deployed.Surgeon took time to try to snare stent out of body without success so he then had to deploy stent in place to prevent migration elsewhere.Patient has stent where she does not need one and we were never able to get sma stented due to this complication.Patient stable with no adverse outcomes.Vendor on site during issue and reported to her quality department at bard.Fda safety report id# (b)(4).

• Brand Name: LIFESTREAM COVERED STENTS X2
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 12087701
• MDR Text Key: 259194377
• Report Number: MW5102196
• Device Sequence Number: 1
• Product Code: PRL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 06/25/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2024
• Device Model Number: LIFESTREAM 7MMX 37MM
• Device Catalogue Number: LSMU1350737
• Device Lot Number: CMFR0263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/23/2021
• 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 Outcome(s): Required Intervention
• Patient Age: 80 YR