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

Model Number H7493893716300

Device Problems Occlusion Within Device (1423); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Enzyme Elevation (1838); Myocardial Infarction (1969); Nausea (1970); Reocclusion (1985); Weakness (2145); Discomfort (2330)

Event Date 04/17/2014

Event Type  Injury  

Event Description

(b)(4) clinical study.It was reported that weakness, chest discomfort and myocardial infarction (mi) occurred.On (b)(6) 2010, the patient presented with shortness of breath with exertion and an abnormal stress test.The patient was referred for cardiac catheterization.Subsequently, coronary angiography and the index procedure was performed.The target lesion was a de-novo lesion, located in the proximal left circumflex (lcx) artery with 95% stenosis and was 12mm long with a reference vessel diameter of 3.0 mm.The lesion was treated with pre-dilatation and placement of a 3.00 x 16mm 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 weakness and ongoing chest discomfort.The patient was hospitalized on the same day.Ecg revealed inverted t-waves replacing nonspecific t-wave abnormality.Troponin was found to be elevated and cardiac enzymes were not consistent with protocol definition of mi.The patient was diagnosed with non q-wave non-st elevation mi.At the time of event, the patient was on aspirin and clopidogrel.The study drug per protocol was last taken on unspecified date in 2011.The site confirmed that no catheterization was performed and the patient was treated medically.Five days post treatment, the event was considered resolved without residual effects and the patient was discharged.

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 the patient was given 200 mcg intracoronary nitroglycerin as part of the index procedure.In (b)(6) 2014 the patient also presented to the emergency department with nausea.In addition, electrocardiogram (ecg) revealed with possible inferolateral injury pattern.Five days from admission, the patient was transferred to a rehabilitation facility with aspirin and clopidogrel.Two days after, the patient was presented to the emergency departement with acute onset of confusion and slurred speech; and was hospitalized on the same day.Physical examination at the time of admission revealed cranial nerves to be intact without any focal deficits.The patient was diagnosed with acute hemorrhagic cerebrovascular accident and degree of impairment was assessed to be "moderate disability." at the time of event, the patient was taking aspirin and clopidogrel and the study drug was last taken on unknown date in 2011.During the course of hospitalization, the patient was also noted to have a brief episode of chest pain with elevated troponins and cardiac catheterization was recommended.Five days from re-admission, coronary angiography revealed:lcx (target vessel) diffusely calcified with 20% in-stent restenosis in the study stent in proximal segment.The patient was recommended to continue medical therapy.The patient was discharged on the following day.

• 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: 3835947
• MDR Text Key: 21173179
• Report Number: 2134265-2014-02862
• 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: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2011
• Device Model Number: H7493893716300
• Device Catalogue Number: 38937-1630
• Device Lot Number: 13329386
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/03/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/19/2010
• 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: 64 YR