MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MAPLE GROVE PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM; STENT, CORONARY, DRUG-ELUTING

Model Number UNK340

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

Patient Problems Bradycardia (1751); Cardiac Arrest (1762); Chest Pain (1776); Death (1802); Dyspnea (1816); Non specific EKG/ECG Changes (1817); Ventricular Tachycardia (2132); Anxiety (2328); Diaphoresis (2452); Loss Of Pulse (2562)

Event Date 01/11/2017

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr.: it is indicated that the device will not be returned for evaluation.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).

Event Description

Same patient as mdr id# 2134265-2017-07120.(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2015, a 2.75x12mm promus stent was implanted in the ramus artery.In (b)(6) 2017, the patient presented to the emergency department for evaluation of chest pain.The patient complained of sternal chest pain and pain between shoulder blades with radiation down to the left arm associated with shortness of breath.The patient received aspirin, morphine sulphate and nitroglycerin in response to chest pain.While the patient was undergoing workup, the patient was noted to have ventricular tachycardia.An electrocardiogram (ekg) was performed which revealed prolongation of pulse rate (pr) interval, no acute ischemia.The patient was defibrillated and received epinephrine.Eventually, the patient was noted to have wide complex tachycardia.Additionally, the patient was moderately anxious and mildly diaphoretic.Ativan was given to calm the patient.Over the next 15 minutes, the patient had respiratory difficulty.Rapid sequence intubation medications were initiated; however, the patient was noted to be unresponsive and had pulseless electrical activity (pea).During intubation, copious secretions were noted.The secretions became more copious and pink frothy.Cardiopulmonary resuscitation (cpr) was continued.The patient received multiple doses of epinephrine and bicarbonate; however, the patient remained in pea and qrs complex was widened gradually.Cpr continued though the patient was unresponsive.The patient was noted to have a couple episodes of fine ventricular tachycardia with a wide complex.This was defibrillated a couple of times.After 20 minutes of second cardiac arrest, the patient was found to be in wide complex bradycardiac pea.Resuscitative efforts were discontinued.On the same day, the patient expired with manner of death reported as natural.Per death certificate, the immediate cause of death was cardiorespiratory arrest with underlying causes as ventricular tachycardia and coronary artery disease.An autopsy was not performed.

• Brand Name: PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6765126
• MDR Text Key: 81774386
• Report Number: 2134265-2017-07939
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/19/2017

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 Model Number: UNK340
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2017
• Initial Date FDA Received: 08/03/2017
• 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
• Patient Age: 63 YR