MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT? PLUS; STENT, CORONARY, DRUG-ELUTING

Model Number H7493911616400

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

Patient Problems Bradycardia (1751); Cardiomyopathy (1764); Death (1802); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Occlusion (1984); Renal Disease, End Stage (2039); ST Segment Elevation (2059); Cardiogenic Shock (2262); Loss of consciousness (2418); Respiratory Failure (2484)

Event Date 01/21/2015

Event Type  Death  

Event Description

It was further reported that in (b)(6) 2015, patient's electrocardiogram (ecg) revealed st elevation myocardial infarction (mi) and also patient's troponin values were elevated.In addition, the physician indicated that the stenting performed in (b)(6) 2015 in saphenous vein graft (svg) to right posterior descending artery (r-pda) was for a de novo lesion and not for the in-stent restenosis (isr) of the previously placed two 4.0 x 20 mm promus element plus stents and 4.0 x 8 mm promus element plus stent as previously reported.

Manufacturer Narrative

(b)(4).

Event Description

Same case as mdr id: 2134265-2015-01341, 2134265-2015-00442, 2134265-2015-00452, 2134265-2015-00453, 2134265-2015-01342 and 2134265-2015-01343.(b)(4) clinical study.It was reported that myocardial infarction and death occurred.In (b)(6) 2012, the patient presented with unstable angina and patient was diagnosed with non q-wave myocardial infarction (mi).Coronary angiography and index procedure were performed.The target lesion was a de novo lesion located in the proximal segment of saphenous vein graft (svg) to distal left circumflex artery (lcx) with 80% stenosis and was 15 mm long with a reference vessel diameter of 4.00 mm.The lesion was treated with direct stent placement using a 4.00x16mm promus element¿ plus stent.Following post-dilatation, transient no reflow was noted which was successfully treated with 600mcg intracoronary nitroglycerin.Residual stenosis was 0%.Target lesion #2 was an ostial de novo lesion located in the proximal segment of svg to 1st diagonal with 99% stenosis and was 8 mm long with a reference vessel diameter of 2.5 mm.The lesion was treated with pre-dilatation and placement of a 2.50x12mm promus element¿ plus stent.Following post dilatation, residual stenosis was 0 %.Three days post procedure, the patient was discharged on aspirin and clopidogrel.In (b)(6) 2013, the patient presented myocardial infarction (mi) and two 4.0 x 20 mm promus element plus stents and 4.0 x 8 mm promus element plus stent were implanted in saphenous vein graft (svg) to right posterior descending artery (r-pda).Two days post procedure, patient had high grade stenosis in distal left circumflex (lcx) and was implanted with 3.00 x 12 mm promus element plus stent in (b)(6) 2014, the patient presented with coronary artery disease (cad) exacerbation and a 4.00 x 20 mm promus element plus stent was implanted in svg to obtuse marginal (om).In (b)(6) 2015, the patient presented due to cad exacerbation and peripheral vascular disease exacerbation.There was isr of the previously placed two 4.0 x 20 mm promus element plus stents and 4.0 x 8 mm promus element plus stent, which was treated stenting in svg to r-pda.Also, the physician treated the peripheral vascular disease with stenting to right superficial femoral artery.Post procedure, the events were considered as resolved.Six days later, the patient presented to emergency room with post episodes of bradycardia followed by near syncope with a recurrent drop of heart rate (30s).Patient was unresponsive, bradycardic and hypotensive which was treated with atropine but eventually patient was intubated.Echocardiogram revealed reduced ejection fraction less than 20% with multiple wall motion abnormalities.Intravenous (iv) epinephrine and significant bolus were given to the patient, resulting in improved blood pressure.The patient was then transported to cardiovascular recovery unit (cvru) and due to poor prognosis, patient's family opted to placed patient under do not resuscitate (dnr) status.Subsequently, patient was then extubated and placed on comfort measures.The patient died on the same day.The cause of death was acute coronary syndrome resulting in severe cardiomyopathy complicated with severe bradycardia with contributing conditions of end stage renal disease on hemodialysis, type 2 diabetes mellitus (dm) and acute respiratory failure related to cardiogenic shock.

Manufacturer Narrative

Device is a combination product.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: PROMUS ELEMENT? PLUS
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY; ballybrit business park; galway
• Manufacturer Contact: linda leimer ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 4573052
• MDR Text Key: 5724362
• Report Number: 2134265-2015-01340
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110010
• 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: 02/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/08/2013
• Device Model Number: H7493911616400
• Device Catalogue Number: 39116-1640
• Device Lot Number: 15531835
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2012
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 66 YR