MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTE PROMUS PREMIER MONORAIL; CORONARY DRUG-ELUTING STENT

Lot Number 18917574

Device Problems Detachment Of Device Component (1104); Premature Activation (1484)

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

Event Date 05/04/2016

Event Type  malfunction  

Event Description

While attempting to deploy a stent, the stent came off the balloon and deployed in the body.The cardiologist ws able to move stent to the femoral artery.Stent removed successfully.Patient discharged 2 days later.Manufacturer response for promus premier monorail, promus premier monorail (per site reporter): manufacturer rep stated that they had not had issues with the device.Maude indicated 1 incident in (b)(6) of the prior year.

• Brand Name: PROMUS PREMIER MONORAIL
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORP., MARINA BAY CUST. FULFILLMENT CENTE; 500 commander shea boulevard; quincy MA 02171
• MDR Report Key: 6330661
• MDR Text Key: 67566455
• Report Number: 6330661
• 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: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Lot Number: 18917574
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/29/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/29/2016
• 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: 58 YR