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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 H7493926020350
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Edema (1820); Hemorrhage/Bleeding (1888)
Event Date 06/20/2017
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
(b)(6) clinical study. It was reported that the patient died. In (b)(6) 2017, the patient presented due to unstable angina (braunwald classification : iiia) and was referred for cardiac catheterization. Subsequently, the index procedure was performed. The target lesion was located in the distal right coronary artery (rca) with 80% stenosis and was 20 mm long with a reference vessel diameter of 3. 5 mm. The target lesion was treated with pre-dilatation and placement of a 3. 50 x 20 mm synergy ii stent with 0% residual stenosis. The following day, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2017, the patient was hospitalized for an event of spontaneous and overt gastrointestinal bleeding. Blood transfusions were performed and four days later, the patient was discharged on aspirin and clopidogrel. In (b)(6) 2017, the patient was re-hospitalized due to bilateral lower extremity edema and was treated medically. Three days later, the patient was discharged on aspirin and clopidogrel. However after thirteen days, the patient died due to an unknown cause.
 
Manufacturer Narrative
(b)(4).
 
Event Description
It was further reported that the patient died due to chronic obstructive pulmonary disease.
 
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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 Key6738690
MDR Text Key80856253
Report Number2134265-2017-07611
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
Report Date 07/13/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/24/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/15/2017
Device Model NumberH7493926020350
Device Catalogue Number39260-2035
Device Lot Number0020002349
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 Received08/28/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/06/2016
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: 07/24/2017 Patient Sequence Number: 1
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