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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 Problems Break (1069); Positioning Failure (1158); Device Dislodged or Dislocated (2923)
Patient Problems Cardiac Arrest (1762); Ischemia (1942); Ventricular Fibrillation (2130); Foreign Body In Patient (2687)
Event Date 12/09/2021
Event Type  Injury  
Event Description
It was reported that a shaft break and stent dislodged occurred. A percutaneous coronary intervention was performed during an acute myocardial infarction, with injury to the proximal and middle anterior descending artery. Following predilation with a balloon, a 3. 50 x 20 synergy stent was advanced to the target lesion, with an attempt to deploy, but the balloon would not inflate. It was noted that with the impossibility of inflating the stent, it was not possible to raise the pressure. At that time, the manometer was exchanged, and was unable to inflate, and so it was decided to remove the stent device. While removing the stent device, the hypotube fractured at the level of the balloon and the stent, extracting only the rest of the hypotube, which complicated the procedure. The balloon coiled and the stent remained in the distal segment of the distal anterior descending artery, causing no reflow and cardiac arrest due to ventricular fibrillation. No further patient complications were reported in relation to this event.
 
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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 Key13018166
MDR Text Key282333083
Report Number2134265-2021-15881
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSP
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
Report Date 12/16/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0027883047
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/12/2021
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: 12/16/2021 Patient Sequence Number: 1
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