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

Model Number H7493893612350

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

Patient Problems Arrhythmia (1721); High Blood Pressure/ Hypertension (1908)

Event Type  Injury  

Manufacturer Narrative

Device is combination product.It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that hypertension and arrhythmia occurred.In (b)(6) 2011, the patient presented with hypertension and arrhythmia.Blockage in the left anterior descending artery (lad) was noted and treated with a 12x3.5mm taxus® liberté® stent.The patient again experiences occasional periods of high blood pressure and arrhythmia which began on an unspecified date.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient experienced symptoms of arrhythmia sometimes with and sometimes without high blood pressure(185/75/52) and tiredness beginning about one year post stent implant.These symptoms would last anywhere from an hour to off and on for several days.

• Brand Name: TAXUS LIBERTE
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7222450
• MDR Text Key: 98404912
• Report Number: 2134265-2018-00253
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P060008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2011
• Device Model Number: H7493893612350
• Device Catalogue Number: 38936-1235
• Device Lot Number: 13366404
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/04/2018
• Initial Date FDA Received: 01/26/2018
• Supplement Dates Manufacturer Received: 02/01/2018
• Supplement Dates FDA Received: 02/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/06/2010
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1