MAUDE Adverse Event Report: CLEARSTREAM TECHNOLOGIES / BARD PERIPHERAL VASCULAR, INC. BARD LIFESTREAM BALLOON EXPANDABLE VASCULAR STENT; ILIAC COVERED STENT, ARTERIAL

Model Number 9MMX38MMX80CM

Device Problem Material Separation (1562)

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

Event Date 02/10/2021

Event Type  malfunction  

Event Description

During tavr, lifestream balloon expandable vasc stent inserted.About five minutes later, stent was found to have come off balloon in body; stent inserted and advanced to femoral.After exploration, removal occurred.Fda safety report id# (b)(4).

• Brand Name: BARD LIFESTREAM BALLOON EXPANDABLE VASCULAR STENT
• Type of Device: ILIAC COVERED STENT, ARTERIAL
• Manufacturer (Section D): CLEARSTREAM TECHNOLOGIES / BARD PERIPHERAL VASCULAR, INC.
• MDR Report Key: 11404142
• MDR Text Key: 234678840
• Report Number: MW5099733
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 02/26/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 9MMX38MMX80CM
• Device Catalogue Number: LSMU0800938
• Device Lot Number: CMCQ0366
• Was Device Available for Evaluation?: Yes
• 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): Other
• Patient Age: 72 YR
• Patient Weight: 34