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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
Lot Number 0028915062
Device Problem Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 02/19/2024
Event Type  Injury  
Event Description
It was reported that stent dislodgement occurred, requiring additional intervention.The stenosed target lesion was about 60 to 70%, located in the mildly tortuous and moderately calcified left anterior descending artery.A 3.00 x 28mm synergy drug-eluting stent was selected for treatment.However, during the procedure, the stent came off the balloon and stayed inside the heart at a curve before the treatment area.Subsequently, the patient was sent for emergency coronary artery bypass surgery.The device still remains in the patient, and no attempts were made to retrieve the stent.No further issues were reported, and the patient was well-conditioned.
 
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Brand Name
SYNERGY XD
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 CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
rachel shields
4100 hamline ave n
arden hills, MN 55112
6512422111
MDR Report Key18875951
MDR Text Key337339446
Report Number2124215-2024-12169
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729980995
UDI-Public08714729980995
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/15/2024
Device Lot Number0028915062
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/19/2024
Initial Date FDA Received03/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
Patient SexMale
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