MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

Model Number H7493926016250

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

Patient Problems Atrial Fibrillation (1729); Cardiomyopathy (1764); Congestive Heart Failure (1783); Death (1802); Dyspnea (1816); Cardiac Enzyme Elevation (1838); Low Blood Pressure/ Hypotension (1914); Renal Failure (2041); Dizziness (2194); Respiratory Failure (2484)

Event Date 01/18/2017

Event Type  Death  

Manufacturer Narrative

Device is a combination product.Device evaluated by mfr: the complaint 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

Same case as mdr id# 2134265-2017-01584 and 2134265-2017-01586 (b)(6) clinical study.It was reported that the patient died.In (b)(6) 2016, the index procedure was performed.Target lesion #1 was located in proximal left anterior descending (lad) artery with 80% stenosis and was 10 mm long with a reference vessel diameter of 3.0 mm.Target lesion #1 was treated with pre-dilatation and placement of a 4.00 x 20 mm synergy ii drug-eluting study stent.Following post-dilatation, there was 0% residual stenosis and timi flow 3.Target lesion #2 was located in the ramus branch with 85% stenosis and was 8 mm long with a reference vessel diameter of 2.5 mm.Target lesion #2 was treated with pre-dilatation and placement of a 2.50 x 16 mm synergy ii drug-eluting study stent.Following post-dilatation, there was 0% residual stenosis and timi flow 3.Target lesion #3 was located in the 1st obtuse marginal branch with 90% stenosis and was 5 mm long with a reference vessel diameter of 2.0 mm.Target lesion #3 was treated with pre-dilatation and placement of a 2.25 x 8 mm synergy ii drug-eluting study stent.Following post-dilatation, there was 0% residual stenosis and timi flow 3.The following day, the patient was discharged on dual antiplatelet therapy.In (b)(6) 2017, the patient presented to the emergency department with the complaints of dizziness with hypotension, shortness with breath with dyspnea on exertion (doe) and orthopnea.The patient was given intravenous fluid (ivf) with which the patient's blood pressure was improved.Cardiology was consulted.Cardiac enzymes were found to be elevated likely due to demand as well as acute renal failure.The patient had some diarrhea and was found to be anemic.Electrocardiogram (ecg) was performed which revealed atrial fibrillation with rapid ventricular response, left bundle branch block.In addition, chest x ray was also performed which revealed right lung base airspace.The patient was diagnosed with congestive heart failure which was attributed to cardiomyopathy, this was complicated by cardiogenic shock, acute hypoxemic respiratory failure, acute kidney injury, hyponatremia, hyperphosphatemia, elevation of liver enzymes and was admitted to the hospital.The patient was supported with vasopressor therapy and required supplemental oxygen.The patient remained in atrial fibrillation and progressively became more and more lethargic and delirious.Despite aggressive supportive measures, the patient's condition did not improve.Two days later, post discussion with the patient's family, all medications and diagnostic tests were discontinued and the patient was placed on comfort care.The patient received morphine for analgesia and lorazepam for anxiety.Subsequently, the patient expired.

Manufacturer Narrative

Event date corrected from (b)(6) 2017.(b)(4).

Event Description

It was further reported that the patient did not have an acute myocardial infarction.It was confirmed that the death of the patient was due to low-output syndrome with multi-organ failure, including demand myocardial ischemia, hepatic and renal failure.The patient also had severe ischemic dilated cardiomyopathy resulting in acute respiratory failure that had led to death.It was confirmed that the interventional procedure and device were not the contributory factors to the patient's death.As per death certificate, the immediate cause of death was cardiogenic shock, secondary cause of death include cardiomyopathic ischemia, coronary artery disease.Other significant contributing factors include acute respiratory failure and acute renal failure.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the patient's death was related to cardiogenic shock and not related to the study device.

• Brand Name: SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
• Type of Device: BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
• 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: 6354393
• MDR Text Key: 68172073
• Report Number: 2134265-2017-01585
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 08714729840091
• UDI-Public: (01)08714729840091(17)20170721(10)0019526363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150003
• 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,Followup
• Report Date: 02/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/21/2017
• Device Model Number: H7493926016250
• Device Catalogue Number: 39260-1625
• Device Lot Number: 0019526363
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2016
• 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: 78 YR