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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 H7493941820250
Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/19/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event: there was no date provided.
 
Event Description
It was reported that stent damage occurred.A 2.50 x 20mm synergy xd drug eluting stent was selected for use.However, the device would not load onto the wire and the stent was damaged.No patient complications were reported.
 
Event Description
It was reported that stent damage occurred.A 2.50 x 20mm synergy xd drug eluting stent was selected for use.However, the device would not load onto the wire and the stent was damaged.No patient complications were reported.It was further reported that it was the stent strut itself that got lifted.The procedure was completed with another of same device.
 
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Brand Name
SYNERGY XD
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key11384810
MDR Text Key234563612
Report Number2134265-2021-02471
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729980810
UDI-Public08714729980810
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/14/2022
Device Model NumberH7493941820250
Device Lot Number0026563096
Was Device Available for Evaluation? No
Date Manufacturer Received03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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