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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 0028860834
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/18/2022
Event Type  malfunction  
Event Description
It was reported that a labelling issue occurred.A 3.00 x 32mm synergy xd drug-eluting stent was selected for use.However, when the packaging was opened, it was found that the stent was unmarked making it unusable.Another of the same device was used and completed the procedure.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr.: synergy xd mr ous 3.00 x 32mm; stent delivery system, catheter was returned for analysis.The device packaging was not received.A visual examination of the stent found stent damage.Stent damage with struts near the proximal region were bunched.The undamaged stent outer diameter was measured, and the result was within max crimped stent profile measurement.The balloon cones were reviewed, and no issues were noted.The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure.A visual and microscopic examination of the bumper tip identified no damage.A visual and microscopic and tactile examination of the hypotube shaft found no kinks or damages.A visual and tactile examination of the outer and mid-shaft section and a visual examination of the inner lumen found no issues along the shaft polymer extrusion.An examination of the hub confirmed that the product details were clearly printed on the hub.
 
Event Description
It was reported that a labelling issue occurred.A 3.00 x 32mm synergy xd drug-eluting stent was selected for use.However, when the packaging was opened, it was found that the stent was unmarked making it unusable.Another of the same device was used and completed the procedure.There were no patient complications reported.
 
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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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
4100 hamline ave n
arden hills, MN 55112
6515810888
MDR Report Key15744421
MDR Text Key303170176
Report Number2124215-2022-44603
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 03/02/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/03/2024
Device Lot Number0028860834
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/28/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2022
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 Age80 YR
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