MAUDE Adverse Event Report: BOSTON SCIENTIFIC - CARDIOVASCULAR GROUP PROMUS PREMIER; CORONARY DRUG-ELUTING STENT

Catalog Number H7493952816300

Device Problems Out-Of-Box Failure (2311); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2016

Event Type  malfunction  

Event Description

Struts were protruding from the tip of a promus stent.This was noted to be an out of box failure.The device will be returned to the manufacturer for evaluation and failure analysis.

• Brand Name: PROMUS PREMIER
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - CARDIOVASCULAR GROUP; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 5569577
• MDR Text Key: 42419048
• Report Number: 5569577
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: H7493952816300
• Device Lot Number: 18803028
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Weight: 75