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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10619
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Dyspnea (1816); Low Blood Pressure/ Hypotension (1914)
Event Date 11/19/2018
Event Type  Death  
Manufacturer Narrative
Device is combination product.
 
Event Description
It was reported the patient expired. A 2. 25 x 20 synergy drug coated stent was implanted to treat a 2. 25x16mm target lesion in the left anterior descending artery. Two hours post procedure the patient expired.
 
Manufacturer Narrative
Device is combination product. Correction to implant date - from (b)(6) 2018 has been changed to (b)(6) 2018.
 
Event Description
It was reported the patient expired. A 2. 25 x 20 synergy drug coated stent was implanted to treat a 2. 25x16mm target lesion in the left anterior descending artery. Two hours post procedure the patient expired. It was further reported the patient was having chest pain on exertion for the last 6 months. On diagnosis the patient was found hypertensive, had lv dysfunction and the ejection fraction was 35-40%. The patient presented to the hospital with severe chest pain. A 2. 25 x 20 synergy drug coated stent was implanted to treat a 2. 25x16mm target lesion in the left anterior descending artery. The patient was normal post procedure. After one hour, the patient started having breathlessness. An electrocardiogram (ecg) was performed and found normal. The patients symptoms were managed medically. After some time the patient suddenly felt hypotensive followed by cardiac arrest. Cardiopulmonary resuscitation (cpr) was performed but the patient could not be revived.
 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
sonali arangil
two scimed place
maple grove, MN 55311
6515827403
MDR Report Key8199372
MDR Text Key131499391
Report Number2134265-2018-64653
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/03/2019
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0021586031
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 Received12/23/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/04/2018
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: 12/27/2018 Patient Sequence Number: 1
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