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

Model Number H7493893716300

Device Problem Occlusion Within Device (1423)

Patient Problems Cardiomyopathy (1764); Occlusion (1984); Reocclusion (1985)

Event Date 07/08/2014

Event Type  Injury  

Event Description

(b)(4) clinical study.It was reported that in-stent restenosis (isr) occurred.In (b)(6) 2010, the patient presented due to complaints of chest discomfort radiating to the arm associated with shortness of breath and was diagnosed with non st elevation myocardial infarction (nstemi).Cardiac catheterization was recommended.Subsequently, coronary angiography and the index procedure were performed.The target lesion was a de novo lesion located in proximal saphenous vein graft (svg) to proximal right coronary artery (rca) with 75% stenosis and was 6.0 mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00 x 16 mm taxus liberte stent, with 0% residual stenosis.Twelve days post procedure, the patient was discharged on aspirin and prasugrel.In (b)(6) 2014, the patient presented for evaluation of cardiomyopathy, nstemi, coronary artery disease (cad) and for a scheduled intervention to the svg to rca.The patient was hospitalized and cardiac catheterization was recommended.At the time of event, the patient was taking aspirin and clopidogrel.The study drug per protocol was never taken during the course of the study.Coronary angiography revealed 99% diffuse isr of the previously placed study stent located in the svg to proximal rca and was treated with balloon angioplasty and placement of a 3.0 mm unknown stent, with 0% residual stenosis.At the time of reporting, the event was considered recovering/resolving.One day post procedure, 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).

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2014, the patient presented with complaints of mild shortness of breath on exertion.Furthermore, the previously reported 3.0 mm unknown stent, is now reported as a non bsc stent.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that in (b)(6) 2014, the patient presented with complaints of syncope, left sided chest pain and was hospitalized.The patient was noted to have hyperkalemia and was treated with kayexalate.Electrocardiogram (ecg) revealed normal sinus rhythm with age determined inferior infarction, prolonged qt interval and t wave inversion less evident in inferior leads.Troponin was found to be elevated and the patient was diagnosed with non st elevation myocardial infarction.At the time of event, the patient was taking aspirin only.The study drug was never taken and other antiplatelet medication was last taken in (b)(6) 2012.Two days from admission, electrocardiogram (ecg) showed anterior infarct with st and t wave abnormality and prolonged qt interval.Coronary angiography was also performed and revealed 90% occlusion with 90% haziness/lucency in saphenous vein graft (svg) to right coronary artery (rca) and was recommended for treatment on a later date.In addition, the 99% stenosis in the non-target vessel proximal left circumflex (lcx) was treated with rotablator and placement of a 2.75 x 8 mm non bsc stent.Two days post procedure, the event was considered resolved without residual effects and the patient was discharged on aspirin and clopidogrel.

• 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 Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4072298
• MDR Text Key: 4743553
• Report Number: 2134265-2014-05423
• 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,Followup,Followup
• Report Date: 08/19/2014

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: 02/14/2011
• Device Model Number: H7493893716300
• Device Catalogue Number: 38937-1630
• Device Lot Number: 12972196
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/14/2014
• Initial Date FDA Received: 09/09/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/13/2014; 12/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2009
• 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: 76 YR