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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 H7493941832300
Device Problems Activation, Positioning or SeparationProblem (2906); Detachment of Device or Device Component (2907)
Patient Problem Insufficient Information (4580)
Event Date 06/23/2021
Event Type  malfunction  
Event Description
During a multivessel percutaneous coronary intervention (pci) with the assistance of an impella. The initial undeployed lad stent came off the balloon in the left main and had to be removed with a 6f guideliner. During removal of the lad stent, the initial wiring of the lad stent was threaded through a strut on the lcx stent, which resulted in unintended removal of the lcx stent.
 
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Brand NameSYNERGY XD
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key12312160
MDR Text Key266205806
Report Number12312160
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/12/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493941832300
Device Catalogue NumberH7493941832300
Device Lot Number26820399
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/10/2021
Event Location No Information
Date Report to Manufacturer08/12/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 08/12/2021 Patient Sequence Number: 1
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