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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 H7493941848300
Device Problems Difficult to Remove (1528); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2021
Event Type  malfunction  
Event Description
It was reported that stent damage occurred.The patient presented with coronary blockage.The target lesion was located in the left anterior descending artery.A 3.00 x 48mm synergy xd drug-eluting stent was selected for use and resistance was encountered when attempting to remove the stent protector from the stent delivery system.After rotating the stylet, the cover was able to be removed.However, it was noticed that the proximal portion of the stent was deformed.The device was removed and the procedure was completed with a new 3.0 x 48 synergy xd stent.No patient complications were reported.
 
Manufacturer Narrative
Device evaluated by mfr: a synergy xd mr us 3.00 x 48mm stent delivery system was returned for analysis.A visual examination of the stent found stent damage.Stent damage with struts near the proximal region were lifted.The undamaged stent outer diameter was measured using snap gauge and the result is 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 damage.A visual and microscopic examination of the inner/wire lumen found that the lumen was damaged.Minor jagged protrusions were visible along the inner/wire lumen.Returned with this device was the stent protector.An examination of the protector identified that the protector was compressed 1 cm proximal to distal region.A visual and tactile examination of the product mandrel identified a kink in the mandrel.The kink was located at 28.5cm distal from the pigtail end.
 
Event Description
It was reported that stent damage occurred.The patient presented with coronary blockage.The target lesion was located in the left anterior descending artery.A 3.00 x 48mm synergy xd drug-eluting stent was selected for use and resistance was encountered when attempting to remove the stent protector from the stent delivery system.After rotating the stylet, the cover was able to be removed.However, it was noticed that the proximal portion of the stent was deformed.The device was removed and the procedure was completed with a new 3.0 x 48 synergy xd stent.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
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI  
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key13117047
MDR Text Key282956869
Report Number2134265-2021-16326
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729985228
UDI-Public08714729985228
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,Followup
Report Date 03/02/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/16/2022
Device Model NumberH7493941848300
Device Lot Number0026263759
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/27/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/25/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/16/2020
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 Age76 YR
Patient SexMale
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