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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

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BOSTON SCIENTIFIC CORPORATION SYNERGY BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10607
Device Problems Defective Device (2588); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Chest Pain (1776); Myocardial Infarction (1969); Thrombosis/Thrombus (4440)
Event Date 12/17/2021
Event Type  Injury  
Event Description
It was reported that stent thrombosis and st-segment elevation myocardial infarction occurred. A 3. 00 x 32 and two 3. 00 x 38 synergy drug-eluting stents were implanted in the right coronary artery (rca). Six hours post stent implantation, the patient presented with chest pain symptoms after the aggrastat drip was discontinued. An angiogram was performed which indicated thrombus was present and intravascular ultrasound (ivus) indicated the stents were well apposed but were a little undersized. The physician post dilated with a 3. 25 non-boston scientific balloon. No further complications were reported. The patient was fully recovered with a good prognosis after the procedure.
 
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Brand NameSYNERGY
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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 Key13232678
MDR Text Key283670430
Report Number2134265-2021-16449
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/11/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10607
Device Catalogue Number10607
Device Lot Number0027145402
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/07/2021
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: 01/11/2022 Patient Sequence Number: 1
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