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

Model Number LSMU1350837

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 08/21/2020

Event Type  Injury  

Event Description

Stent placement - put in pt and stent was detached from the balloon.Lifestream bard product 8mmx37mmx135cm.Fda safety report id# (b)(4).

• Brand Name: LIFESTREAM STENT
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 10852020
• MDR Text Key: 216891725
• Report Number: MW5097925
• 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: Nurse
• Type of Report: Initial
• Report Date: 11/12/2020

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
• Device Model Number: LSMU1350837
• Device Catalogue Number: LSMU1350837
• Device Lot Number: CMDW0167
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/16/2020
• 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: 61 YR
• Patient Weight: 81