MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; STENT, CORONARY, DRUG-ELUTING

Model Number UNK717

Device Problem Occlusion Within Device (1423)

Patient Problems Bradycardia (1751); Cardiomyopathy (1764); Death (1802); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Myocardial Infarction (1969); Reocclusion (1985); Renal Disease, End Stage (2039); ST Segment Elevation (2059); Cardiogenic Shock (2262); Loss of consciousness (2418); Respiratory Failure (2484)

Event Date 01/15/2015

Event Type  Death  

Event Description

Same case as mdr id: 2134265-2015-01340, 2134265-2015-01341, 2134265-2015-01342 and 2134265-2015-01343.It was further reported that in (b)(6) 2015, the events (coronary artery disease exacerbation, peripheral vascular disease exacerbation and in-stent restenosis of previously placed two 4.0 x 20 mm promus element plus stents and 4.0 x 8 mm promus element plus stent) were considered as resolved post procedure and not in (b)(6) 2015 as previously reported.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.

Event Description

Same case as mdr id: 2134265-2015-00442 and 2134265-2015-00453.(b)(4).It was reported that in-stent restenosis (isr) occurred.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).In (b)(6) 2015, the patient presented due to coronary artery disease (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.In (b)(6) 2015, the events were considered as resolved.

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

Device is combination product.Device evaluated by mfr: the complaint device was not received for analysis.The batch number is unknown and the manufacturing records for the complaint device could not be reviewed.The root cause is anticipated procedural complications as this event is a known physiological effect of the procedure and is noted within the dfu.(b)(4).

Manufacturer Narrative

Outcomes attrib.To ae- corrected from required intervention to death.Type of reportable event- corrected from serious injury to death.(b)(4).

Manufacturer Narrative

(b)(4).

• Brand Name: PROMUS ELEMENT PLUS EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• 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: 4475936
• MDR Text Key: 5461309
• Report Number: 2134265-2015-00452
• 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,Followup
• Report Date: 01/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UNK717
• 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
• 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; Required Intervention
• Patient Age: 66 YR