MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TAXUS LIBERTE; CORONARY DRUG-ELUTING STENT

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 11/01/2017

Event Type  Injury  

Manufacturer Narrative

Device is combination product.

Event Description

It was reported that following implantation of a taxua drug eluting stent, a drug induced lung injury occurred.

• Brand Name: TAXUS LIBERTE
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8153489
• MDR Text Key: 130019914
• Report Number: 2134265-2018-63885
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 12/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/12/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other