MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTER PROMUS PREMIER; DRUG ELUDING STENT

Lot Number 17122001

Device Problems Bent (1059); Collapse (1099); Kinked (1339)

Patient Problem No Information (3190)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

Prior to intervention, the physician loaded the stent onto the wire and the stent collapsed in the middle and seemed bent.The physician examined the stent and confirmed it was kinked.There was no manipulation of the stent while loading or removing from the stylet.

• Brand Name: PROMUS PREMIER
• Type of Device: DRUG ELUDING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTER; 500 commander shea boulevard; quincy MA 02171
• MDR Report Key: 4278837
• MDR Text Key: 16988886
• Report Number: 4278837
• Device Sequence Number: 1
• Product Code: NIU
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Lot Number: 17122001
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 11/26/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1