MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY¿; CORONARY DRUG-ELUTING STENT

Model Number H7493919920300

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: the device was not returned for analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause was unable to be determined.(b)(4).

Event Description

(b)(6) clinical study.It was reported that the patient died.In (b)(6) 2013, clinical status assessment indicated that the patient's qualifying condition was unstable angina and prior to index procedure the patient was also found to have elevated biomarkers indicative of ischemia.Subsequently, the index procedure was performed.The target lesion was located in the ramus artery with 90% stenosis and was 15 mm long with a reference vessel diameter of 3.0 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 20 mm study stent.Following post-dilatation, residual stenosis was 0%.On the following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient expired.The cause of death is unknown.

Manufacturer Narrative

(b)(4).

Event Description

Same patient as mdr id# 2134265-2017-07939 it was further reported that in january 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 electorcardiogram (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: SYNERGY¿
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6722217
• MDR Text Key: 80327908
• Report Number: 2134265-2017-07120
• 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,Followup
• Report Date: 06/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/09/2013
• Device Model Number: H7493919920300
• Device Lot Number: 15671416
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/19/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/27/2012
• 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: 63 YR