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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 10618
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Bradycardia (1751); Ischemia (1942); Myocardial Infarction (1969); Pulmonary Edema (2020); Tachycardia (2095)
Event Date 11/11/2021
Event Type  Death  
Event Description
It was reported that patient death occurred. A live broadcast of a high risk percutaneous coronary intervention, with a culotte technique approach, was performed on a bifurcated lesion located in the left main, left circumflex, and ostial marginal artery. The patient was noted to have presented to the case in poor condition, with a history of diabetes. 035/180/3 mm amplatz guidewire, 2. 00 mm x 15 mm emerge balloon, two 2. 50 mm x 15 mm emerge balloons, 4. 00 mm x 12 mm emerge balloon, 2. 25 mm x 12 mm emerge balloon, 4. 00 mm x 6 mm emerge balloon, 2. 25 x 16 synergy stent, 3. 00 x 16 synergy stent, 2. 25 x 28 synergy stent, 2. 00 mm x 20. 00 mm agent dcb, and opticross hd vascular imaging were used to treat the patient. It was noted that the stents were deployed and no issues with any of the devices occurred. Following treatment with the devices, the patients condition descending rapidly due to the intervention, but was noted to not be considered device related. The patient went into pulmonary edema, was intubated, and then ultimately passed away.
 
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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 Key12925968
MDR Text Key281684019
Report Number2134265-2021-15326
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 02/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/03/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10618
Device Catalogue Number10618
Device Lot Number0027700328
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/02/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/12/2021
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: 12/03/2021 Patient Sequence Number: 1
Treatment
035/180/3 MM AMPLATZ GUIDEWIRE-BSC; 2.00 MM X 15 MM EMERGE BALLOON-BSC; 2.00 MM X 20.00 MM AGENT DCB MR-BSC; 2.25 MM X 12 MM NC EMERGE BALLOON-BSC; 2.25 X 28 SYNERGY STENT-BSC; 2.50 MM X 15 MM NC EMERGE BALLOON-BSC; 2.50 MM X 15 MM NC EMERGE BALLOON-BSC; 3.00 X 16 SYNERGY STENT-BSC; 4.00 MM X 12 MM NC EMERGE BALLOON-BSC; 4.00 MM X 6 MM NC EMERGE BALLOON-BSC; OPTICROSS HD-BSC
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