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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY XD CORONARY DRUG-ELUTING STENT

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BOSTON SCIENTIFIC CORPORATION SYNERGY XD CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number H7493941812400
Device Problems Break (1069); Difficult to Remove (1528); Material Rupture (1546); Material Deformation (2976)
Patient Problem Foreign Body In Patient (2687)
Event Date 05/21/2021
Event Type  Injury  
Event Description
It was reported that a balloon rupture, shaft break and surgery occurred. The target lesion had moderately to severe tortuosity. A 48mm synergy xd balloon expandable stent was advanced and deployed through the tortuous left anterior descending artery between two previously placed stents. Another 12mm synergy balloon expandable stent was advanced within the distal lesion and the balloon was inflated to 4atm and the balloon ruptured. It was noted that during advancement the shaft of the delivery system may have kinked. During removal, the 12mm synergy balloon expandable stent became caught and the shaft of the delivery system broke. The patient was sent for surgery to remove the detached portion of the shaft. No further patient complications were reported.
 
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Brand NameSYNERGY XD
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 Key11949533
MDR Text Key254603401
Report Number2134265-2021-07335
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Risk Manager
Type of Report Initial,Followup,Followup,Followup
Report Date 06/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493941812400
Device Lot Number0026345138
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Date Manufacturer Received06/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/03/2020
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: 06/07/2021 Patient Sequence Number: 1
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