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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 10617
Device Problems Device Damaged by Another Device (2915); Failure to Deflate (4060)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2024
Event Type  malfunction  
Manufacturer Narrative
B3: as the event date was not reported, the first day in the month of the aware date is provided.
 
Event Description
It was reported that stent damage occurred.A 3.00 x 12 synergy stent balloon expandable was selected for percutaneous coronary intervention procedure.During the procedure, synergy concertinaed upon pulling of side branch wire.Stent was implanted and procedure was completed successfully.No patient complications were reported.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18759172
MDR Text Key336006919
Report Number2124215-2024-10475
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUK
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/22/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/22/2024
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10617
Device Catalogue Number10617
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/29/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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