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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 H7493926038300
Device Problem Occlusion Within Device (1423)
Patient Problems Chest Pain (1776); Death (1802); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 02/14/2017
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
Same case as: 2134265-2017-01775 and 2134265-2017-01777. It was reported that the patient experienced thrombosis, chest pain, st elevations and expired. The patient presented with a st elevated myocardial infarction. The target lesion was located in the 90% stenosed, mildly tortuous and mild to moderately calcified right coronary artery (rca). Three synergy ii stents were implanted overlapping in the rca; a 3. 00 x 38 in the proximal to mid rca, another 3. 00 x 38 in the mid rca, and a 3. 50 x 12 in the distal rca. The procedure was completed and heparin bivalirudin, and clopidogrel blood thinning medication was administered. The patient was in recovery for 2-3 hours when chest pain and st elevations occurred. The patient was transferred back to the cardiac cath lab for treatment. The following day all 3 stents had complete thrombosis and angiojet thrombectomy was performed, however the patient expired.
 
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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 Key6393872
MDR Text Key69554446
Report Number2134265-2017-01776
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 02/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/09/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/28/2017
Device Model NumberH7493926038300
Device Catalogue Number39260-3830
Device Lot Number19825555
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 Received02/14/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/24/2016
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: 03/09/2017 Patient Sequence Number: 1
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