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 Chest Pain (1776); Myocardial Infarction (1969); Nausea (1970); Thrombosis (2100); Diaphoresis (2452)

Event Date 01/19/2014

Event Type  Injury  

Event Description

Same case as mdr id: 2134265-2014-01538.(b)(4).It was reported that stent thrombosis, substernal chest pain associated with diaphoresis and nausea occurred.On (b)(6) 2010, the patient presented with 4 months history of mild chest pain associated with left sided jaw pain and was diagnosed with stable angina.Cardiac catheterization was recommended.Subsequently, coronary angiography and index procedure was performed.Target lesion #1 was a denovo lesion located in the mid left anterior descending (lad) with 99% stenosis and was 8 mm long with a reference vessel diameter of 3.0 mm.Target lesion #1 was treated with direct stent placement using a 3.50 x 12 mm taxus liberté stent.Following post dilatation residual stenosis was 0%.Target lesion #2 was a denovo lesion located in the proximal lad with 75-80% stenosis and was 8 mm long with a reference vessel diameter of 3.5 mm.Target lesion#2 was treated with direct stent placement using a 3.50 x 12 mm taxus liberté stent.Following post dilatation, residual stenosis was 0%.One day post procedure, the patient was discharged on aspirin and prasugrel.On (b)(6) 2014, the patient presented with episodes of sudden substernal crushing chest pain associated with diaphoresis and nausea and patient was hospitalized immediately.Electrocardiogram (ecg) changes were indicative of ischemia.Troponin was drawn however value is unknown.At the time of the event, the subject was on aspirin only.The study drug per protocol was never taken during the study and other anti-platelet medication was last taken on (b)(6) 2014.The patient was diagnosed with non-st elevation myocardial infarction on the following day and cardiac catheterization was recommended.Then two days from admission, coronary angiography revealed stent thrombosis in proximal lad and filling defect associated with proximal lad.The patient was treated medically.Two days from admission, the event was 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).

Manufacturer Narrative

Describe event or problem-corrected and updated.(b)(4).

Event Description

It further reported that the study stent implanted in mid lad was 3.00x12 taxus liberte stent and not 3.5x12 taxus liberte stent as previously reported.The stent thrombosis was noted in proximal lad extending to mid lad.In addition, angiography without revascularization was performed.

• 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: 3723008
• MDR Text Key: 4234988
• Report Number: 2134265-2014-01966
• 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
• Report Date: 03/24/2014

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: 01/29/2011
• Device Model Number: H7493893612300
• Device Catalogue Number: 38936-1230
• Device Lot Number: 12923052
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/29/2014
• Initial Date FDA Received: 04/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2009
• 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: 44 YR