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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); Activation, Positioning or SeparationProblem (2906); Pressure Problem (3012)
Patient Problem Insufficient Information (4580)
Event Date 05/21/2021
Event Type  Injury  
Event Description
A 4. 0 x 48 mm stent was carefully positioned in between the two stents that had been implanted in 2017. After multiple fluoroscopy confirmation, the stent was deployed and post-dilated with a 4. 0 x 20 mm balloon that was sequentially inflated within the stent up to 20 atmospheric pressure. Completion angiogram showed that there was an intervening segment between the distal and the freshly deployed stent. A 4. 0 x 12 mm synergy drug-eluting stent was carefully positioned, and was attempted to be deployed, but unfortunately it would not go up to the nominal pressure. In fact, there was a loss of pressure during stent deployment from 4 to 5 atmospheric pressure. Repeated attempts did not deploy the stent. There was a partially inflated balloon in the stented segment. Attempts to get negative suction failed to retrieve all the contrast. It was decided to retrieve the delivery system, and on gentle retrieval it was noted that the stent shaft has broken into the left anterior descending arterial system. The patient was transferred to the or for an emergent lima lad life-saving coronary artery bypass procedure with transcoronary retrieval of the broken 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 Key11974088
MDR Text Key255363812
Report Number11974088
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 Risk Manager
Type of Report Initial
Report Date 06/01/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberH7493941812400
Device Catalogue NumberH7493941812400
Device Lot Number26345138
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/01/2021
Event Location Hospital
Date Report to Manufacturer06/10/2021
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: 06/10/2021 Patient Sequence Number: 1
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