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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 0028788483
Device Problem Entrapment of Device (1212)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/19/2024
Event Type  malfunction  
Event Description
It was reported that stent entrapment occurred.During the procedure, a 3.50 x 48mm synergy xd drug-eluting stent was advanced to treat the lesion.However, it was noticed that the stent was stuck in the guidewire.The procedure was completed with a different device.No patient complications were reported.
 
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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 Key18705811
MDR Text Key335442397
Report Number2124215-2024-04048
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial
Report Date 02/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/19/2024
Device Lot Number0028788483
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/22/2024
Initial Date FDA Received02/14/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/19/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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