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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 10620
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Myocardial Infarction (1969); ST Segment Elevation (2059); Thrombosis (2100); Cardiogenic Shock (2262)
Event Date 09/24/2020
Event Type  Death  
Event Description
It was reported that st-segment elevation myocardial infarction and acute stent thrombosis occurred and the patient died. In (b)(6) 2020, the patient was treated for coronary artery disease for lesions in the proximal left anterior descending (lad) and circumflex (cx) arteries. A 3. 00 x 38 synergy drug-eluting stent was implanted in the proximal lad and a 3. 00 x 24 synergy drug-eluting stent was implanted in the mid cx. Both stents were post dilated under flouro - no ivus. The procedure was considered successful and no patient complications were reported. On the following day, the patient was discharged with dual antiplatelet therapy of aspirin and clopidogrel. Two days post procedure, the patient suffered an out of hospital arrest with st-segment elevation myocardial infarction (stemi) and was admitted to the hospital in cardiogenic shock and was taken to the cath laboratory. The angiogram demonstrated acute stent thrombosis in both synergy stents that was implanted 2 days prior. Balloon angioplasty was performed on both stents; however, one vessel would perfuse with coronary flow and then would thrombose again. On the same day, the patient died. It was unknown if autopsy was performed.
 
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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 CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10683655
MDR Text Key211471989
Report Number2134265-2020-13818
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date01/13/2022
Device Model Number10620
Device Catalogue Number10620
Device Lot Number0025069539
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 Received09/26/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/14/2020
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: 10/15/2020 Patient Sequence Number: 1
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