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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 H7493926020300
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Edema (1820); Myocardial Infarction (1969)
Event Date 07/01/2018
Event Type  Death  
Manufacturer Narrative
Device is a combination product. Device evaluated by mfr: the complaint device was not received for analysis. The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications. The investigation conclusion was unable to be determined. (b)(4).
 
Event Description
(b)(6). It was reported that myocardial infarction and death occurred. In (b)(6) 2017, the subject was referred for elective cardiac catheterization. Target lesion #1 was located in proximal right coronary artery (rca) with 95% stenosis and was 18 mm long with a reference vessel diameter of 3 mm. Target lesion #1 was treated with pre-dilatation and placement of a 3. 00 x 20 mm study stent. Following post dilatation, there was 0% residual stenosis. The subject was discharged on aspirin and ticagrelor. In (b)(6) 2018, the subject experienced shortness of breath at home and was found pulseless. The subject was unresponsive for five minutes. Emergency medical service (ems) initiated cardiopulmonary resuscitation (cpr) and provided medications. The ems achieved return of spontaneous circulation. The subject presented in the emergency department in cardiac arrest and was unresponsive. The subject was noted to have bradycardia and their end tidal carbon dioxide went down. The subject received medications and five more rounds of cpr. The advanced cardiovascular life support was restarted and was continued for about twenty minutes. The return of spontaneous circulation was never obtained and no cardiac activity was noted. The total downtime of the subject was roughly sixty minutes. Cause of death was cardiac arrest, likely due to myocardial infarction with flash pulmonary edema.
 
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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 Key7715453
MDR Text Key114876329
Report Number2134265-2018-06606
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
Report Date 07/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/14/2018
Device Model NumberH7493926020300
Device Catalogue Number39260-2030
Device Lot Number0020808554
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 Received07/03/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2017
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: 07/24/2018 Patient Sequence Number: 1
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