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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT
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BOSTON SCIENTIFIC CORPORATION SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10617
Device Problems Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 12/01/2020
Event Type  malfunction  
Event Description
It was reported that a stent dislodged.A 4.00 x 12 synergy ii drug eluting stent was used for treatment of a vessel, but while removing the device, the stent dislodged inside the catheter.It was noted that another non boston scientific stent was used with the synergy stent during this procedure.No patient complications were reported in relation to this event.
 
Manufacturer Narrative
Correction: b5: describe event or problem has been updated with the correct event description.H1: type of reportable event: serious injury to: malfunction h6: device codes: from: device dislodged or dislocated 2923 to: adverse event without identified device or use problem.
 
Event Description
It was reported that a stent dislodged.A 4.00 x 12 synergy ii drug eluting stent was used for treatment of a vessel, but while removing the device, the stent dislodged inside the catheter.It was noted that another non boston scientific stent was used with the synergy stent during this procedure.No patient complications were reported in relation to this event.It was later clarified and corrected that this issue was with a non boston scientific (bsc) stent and there was no issue with the 4.00 x 12 synergy ii drug eluting stent.The non bsc device was advanced to the vessel, but while removing the device, the stent dislodged inside the catheter.The 4.00 x 12 synergy ii stent was advanced for treatment and completed the procedure.No patient complications were reported in relation to this event.
 
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Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
MDR Report Key10971961
MDR Text Key220430699
Report Number2134265-2020-17125
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 01/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/08/2020
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 Number10617
Device Catalogue Number10617
Device Lot Number0025664915
Was Device Available for Evaluation? No
Date Manufacturer Received12/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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