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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 H7493941832500
Device Problem Material Rupture (1546)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: used the first date of the month of the aware date as no event date was provided.
 
Event Description
It was reported that balloon rupture occurred.A 5.00 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noticed that there was a blood came back up into the endoflator which was attached to the monorail portion of the stent.When the device was pulled out, a hole in the balloon portion of the stent delivery system was noted.The procedure was completed with another stent and no patient complications were reported.
 
Event Description
It was reported that balloon rupture occurred.A 5.00 x 32mm synergy xd drug-eluting stent was advanced for treatment.However, during procedure, it was noticed that there was a blood came back up into the endoflator which was attached to the monorail portion of the stent.When the device was pulled out, a hole in the balloon portion of the stent delivery system was noted.The procedure was completed with another stent and no patient complications were reported.It was further reported that the 80%-90% stenosed, non-tortuous, eccentric target lesion was located in the mid right coronary artery.
 
Manufacturer Narrative
B3 date of event was corrected from (b)(6) 2020.
 
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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 Key11017916
MDR Text Key221786142
Report Number2134265-2020-17790
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729981299
UDI-Public08714729981299
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/24/2022
Device Model NumberH7493941832500
Device Lot Number0025663506
Was Device Available for Evaluation? No
Date Manufacturer Received12/16/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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