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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 10632
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Ischemia (1942); Ventricular Fibrillation (2130)
Event Date 01/25/2022
Event Type  Death  
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported that a patient death occurred. An angioplasty was performed on a left main coronary artery (lmca) to left anterior descending artery (lad) and right coronary artery (rca). A 2. 75 x 48 synergy stent and another 2. 75 x 48 synergy stent were deployed at the target lesions. Following deployment, the patient had no flow in the lad and left circumflex (lcx), incessant ventricular tachycardia and ventricular fibrillation vt/vf, which led to refractory arrhythmia. The procedure was unsuccessful, and the patient passed away. It was noted that the patient death occurred due to refractory arrhythmia. It was noted that physician did not consider the device or the procedure to have caused or contributed to the patient complications.
 
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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 Key13528531
MDR Text Key285600227
Report Number2134265-2022-01590
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial
Report Date 02/14/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number10632
Device Catalogue Number10632
Device Lot Number0027535519
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/25/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/09/2021
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: 02/14/2022 Patient Sequence Number: 1
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