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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 H7493941820500
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Event Description
It was reported that deflation failure occurred.The 80%stenosed target lesion was located in the non tortuous and non calcified saphenous vein graft.A 5.00 x 20mm synergy xd drug-eluting stent was deployed at nominal pressure for treatment.Post stent deployment, it was observed that the balloon did not deflate properly and the balloon did not rewrap.After the balloon was deflated for one minute, an attempt was made to remove the balloon but it would not go back into the 6 fr guide catheter.An indeflator was attached and pulled negative pressure several times and the balloon was finally pulled back into the guide catheter and removed in partially inflated state to complete the procedure.There were no patient complications reported.
 
Manufacturer Narrative
Device evaluated by mfr: a synergy xd mr ous us 5.00 x 20mm stent delivery system was returned for analysis without the stent.An examination of the crimped stent found that the stent was not returned for analysis as it was successfully deployed at the lesion site.The balloon was reviewed, and it appeared to be in a deflated state with signs of positive pressure being applied to its cones noted.A visual and microscopic examination of the bumper tip showed no issues.A visual and tactile examination of the hypotube found multiple kinks along the length of the hypotube shaft.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.The device was soaked overnight in a water bath at 37 degrees.The device was tracked without issues on a 0.0140 test guidewire and loaded without issues on a 6f test guidecatheter.An inflation/deflation test was performed using an encore device verified with a druck gauge to 16 atmospheres and the device inflated, maintained pressure, and deflated within 26 seconds as per instructions for use.No leaks, loss of pressure or any other damage was noted on the balloon.No other issues were identified during the product analysis.
 
Event Description
It was reported that deflation failure occurred.The 80%stenosed target lesion was located in the non tortuous and non calcified saphenous vein graft.A 5.00 x 20mm synergy xd drug-eluting stent was deployed at nominal pressure for treatment.Post stent deployment, it was observed that the balloon did not deflate properly and the balloon did not rewrap.After the balloon was deflated for one minute, an attempt was made to remove the balloon but it would not go back into the 6 fr guide catheter.An indeflator was attached and pulled negative pressure several times and the balloon was finally pulled back into the guide catheter and removed in partially inflated state to complete 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
MDR Report Key12105173
MDR Text Key259638021
Report Number2134265-2021-08456
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729981268
UDI-Public08714729981268
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/11/2021
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 Date06/22/2022
Device Model NumberH7493941820500
Device Lot Number0025648746
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/28/2021
Initial Date Manufacturer Received 06/17/2021
Initial Date FDA Received07/01/2021
Supplement Dates Manufacturer Received07/28/2021
Supplement Dates FDA Received08/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age62 YR
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