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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
Device Problems Deflation Problem (1149); Difficult to Remove (1528)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2021
Event Type  malfunction  
Event Description
It was reported that slow balloon deflation and removal difficulty occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the deflation time of the balloon in stent was slow and did not change after the contrast concentration was changed.The stent was deployed and the balloon was sticky when exiting a stent.Removal of the balloon from the stent caused the guide catheter to move forward into the left main.There were no patient complications nor injuries reported.
 
Event Description
It was reported that slow balloon deflation and removal difficulty occurred.The 100% stenosed target lesion was located in the mildly tortuous and moderately calcified vessel.A synergy xd drug-eluting stent was advanced for treatment.However, during the procedure, it was noted that the deflation time of the balloon in stent was slow and did not change after the contrast concentration was changed.The stent was deployed and the balloon was sticky when exiting a stent.Removal of the balloon from the stent caused the guide catheter to move forward into the left main.There were no patient complications nor injuries reported.It was further reported that the only information available for this event was.A synergy xd drug-eluting stent was selected for use; however, balloon slow deflation and balloon withdrawal resistance from the stent was observed.No patient complications were reported.
 
Manufacturer Narrative
B3: event date update from (b)(6) 2021 to (b)(6) 2021 date of event estimated based on aware date.B5: describe event or problem: updated.E1:initial reporter information: updated.D6a:implant date: updated from (b)(6) 2021 to (b)(6) 2021 implant date estimated based on aware date.
 
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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 Key11296554
MDR Text Key230952289
Report Number2134265-2021-01060
Device Sequence Number1
Product Code NIQ
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 02/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Date Manufacturer Received01/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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