MAUDE Adverse Event Report: BIOTRONIK AG STENT; CORONARY DRUG-ELUTING STENT

Model Number 401729

Device Problems Loose or Intermittent Connection (1371); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 06/26/2019

Event Type  Injury  

Event Description

Stent separated from balloon before proper deployment requiring add'l intervention to secure the floating stent.While advancing stent, stent separated from balloon without being deployed and was floating in the artery.Another stent inserted and deployed over loose stent mashing it to the wall.A non-compliant balloon was inserted and taken up to high pressure to ensure loose stent was tightly trapped.A third stent was deployed to fix the stenosis without further incident.

• Brand Name: STENT
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BIOTRONIK AG
• MDR Report Key: 8780669
• MDR Text Key: 150878989
• Report Number: MW5088019
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• 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: 07/05/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 401729
• Device Lot Number: 04191391
• 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): Required Intervention
• Patient Age: 52 YR