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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
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BOSTON SCIENTIFIC CORPORATION SYNERGY; BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Device Problems Material Rupture (1546); Failure to Advance (2524); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/07/2020
Event Type  malfunction  
Event Description
It was reported that balloon tear occurred.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified middle left anterior descending artery.A 2.5x38 nc emerge balloon catheter was advanced for dilatation.However, the device failed to cross the lesion and the balloon was torn.The procedure was completed with another of the same device.There were no patient complications reported and the patient was stable.
 
Event Description
It was reported that balloon rupture occurred.The 85% stenosed target lesion was located in the moderately tortuous and severely calcified middle left anterior descending artery.A 2.5x38 nc emerge balloon catheter was advanced for dilation.However, during inflation, the balloon was torn.The procedure was completed with another of the same device.There were no patient complications nor injuries reported.
 
Manufacturer Narrative
D1: "nc emerge" was updated to "synergy.".
 
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Brand Name
SYNERGY
Type of Device
BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10114589
MDR Text Key193733153
Report Number2134265-2020-06307
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 07/08/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/03/2020
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 Received06/12/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age74 YR
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