MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE TAXUS® LIBERTÉ®; CORONARY DRUG-ELUTING STENT

Model Number H7493893612300

Device Problem Occlusion Within Device (1423)

Patient Problems Arrhythmia (1721); Chest Pain (1776); Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Thrombosis (2100); Cardiogenic Shock (2262); Sweating (2444)

Event Date 04/21/2014

Event Type  Injury  

Event Description

Same case as mdr id: 2134265-2014-02766.(b)(4).It was reported that chest pain associated with diaphoresis, nonproductive cough, cardiogenic shock, myocardial infarction (mi) and in-stent thrombosis occurred.In (b)(6) 2010, the patient was diagnosed with q- wave st-elevation myocardial infarction (stemi) and cardiac catheterization was recommended.The index procedure was performed.Target lesion #1 was a de novo lesion located in proximal right coronary artery (rca) with 90% stenosis and was 20 mm long with a reference vessel diameter of 3.5 mm.The lesion was treated with direct stent placement using 3.50 x 28 mm taxus liberté stent, with 0% residual stenosis.Following stent in proximal rca, a grade ¿a¿ dissection was noted at the distal segment of stent and was treated with placement of a 3.00 x 12 mm taxus liberté bailout stent in an overlapping manner.Two days post-procedure, the patient was discharged on aspirin and prasugrel.In april 2014, the patient presented due to chest pain associated with diaphoresis and unproductive cough.Electrocardiogram (ecg) revealed second degree av block, right bundle branch block (rbbb) and possible inferior infarct.Cardiac enzymes were found to be elevated.Q-wave mi and cardiogenic shock occurred.At the time of event, the patient was taking aspirin only and the study drug was last taken in november 2012.Coronary angiography was performed and revealed 100% in-stent thrombosis.The patient was referred for percutaneous coronary intervention.An attempt was made to treat the occluded proximal rca extending to mid rca however, failed due to inability of the interventional wire to cross the lesion.The procedure was aborted.Ttp and an intraaortic balloon pump (iabp) were placed due to hemodynamic instability.The patient was treated medically and with hydration.Two days from procedure, the events were considered to be resolved without residual effects and the patient was discharged on aspirin and clopidogrel.

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: it is indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.A review of the batch history, historical trending, and similar complaint trending review for the product family will be conducted.If there is any further relevant information from that review, a supplemental medwatch will be filed.(b)(4).

• Brand Name: TAXUS® LIBERTÉ®
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: ingrid matte ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 3825299
• MDR Text Key: 4398808
• Report Number: 2134265-2014-02769
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2011
• Device Model Number: H7493893612300
• Device Catalogue Number: 38936-1230
• Device Lot Number: 0013003633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR