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U.S. Department of Health and Human Services

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

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BOSTON SCIENTIFIC - GALWAY SYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number H7493926008220
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 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# 2134265-2017-01585 and 2134265-2017-01584. (b)(4) 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 10mm long with a reference vessel diameter of 3. 0mm. Target lesion #1 was treated with pre-dilatation and placement of a 4. 00x20mm 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 8mm long with a reference vessel diameter of 2. 5mm. Target lesion #2 was treated with pre-dilatation and placement of a 2. 50x16mm 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 5mm long with a reference vessel diameter of 2. 0mm. Target lesion #3 was treated with pre-dilatation and placement of a 2. 25x8mm 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
Describe event or problem updated. (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.
 
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Brand NameSYNERGY II EVEROLIMUS-ELUTING PLATINUM CHROMIUM CORONARY STENT SYSTEM
Type of DeviceBIODEGRADABLE 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 Key6354374
MDR Text Key68172995
Report Number2134265-2017-01586
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
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 Received02/23/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date04/06/2017
Device Model NumberH7493926008220
Device Catalogue Number39260-0822
Device Lot Number19138802
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/04/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/25/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 02/23/2017 Patient Sequence Number: 1
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