MAUDE Adverse Event Report: BOSTON SCIENTIFIC PROMUS PREMIER STENT

Model Number 3.0 X 16

Device Problems Break (1069); Entrapment of Device (1212); Retraction Problem (1536); Failure to Advance (2524)

Patient Problem No Information (3190)

Event Date 04/04/2017

Event Type  Injury  

Event Description

When md was advancing stent through the distal left main artery, the front edge of the stent became trapped within ostial left anterior descending calcification.Unable to advance or retract stent.Md attempted to pull the stent back further and experienced stripping of the stent off of the delivery balloon.Stent with smaller balloon tried.

• Brand Name: PROMUS PREMIER STENT
• Type of Device: PROMUS PREMIER STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752 1234
• MDR Report Key: 6497093
• MDR Text Key: 73074075
• Report Number: MW5069105
• Device Sequence Number: 1
• Product Code: NIQ
• 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: 04/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/25/2018
• Device Model Number: 3.0 X 16
• Device Catalogue Number: H7493952811630O
• Device Lot Number: 19921176
• 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: 70 YR