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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 10620
Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
Event Date 10/09/2020
Event Type  Injury  
Event Description
It was reported that a difficulty crossing a previously placed stent, a stent detached from the balloon, unretrieved device fragment, and additional intervention occurred.The target lesion was located in the tortuous right coronary artery (rca).It was noted that stent was previously implanted in the vessel, but was not fully expanded.A 3.50 x 24 synergy stent was advanced, but was unable to advance in the in stent restenosis (isr).A non boston scientific extension catheter was used, but the synergy stent could still not be delivered.During an attempt to remove the stent delivery system (sds) in the extension catheter, the stent became lost.In an attempt to remove the detached stent, a snare was advanced, but removing the stent was not successful.Another stent was then advanced to crush the lost stent and successfully complete the procedure.No patient complications resulted in relation to this event.
 
Event Description
It was reported that a difficulty crossing a previously placed stent, a stent detached from the balloon, unretrieved device fragment, and additional intervention occurred.The target lesion was located in the tortuous right coronary artery (rca).It was noted that stent was previously implanted in the vessel, but was not fully expanded.A 3.50 x 24 synergy stent was advanced, but was unable to advance in the in stent restenosis (isr).A non boston scientific extension catheter was used, but the synergy stent could still not be delivered.During an attempt to remove the stent delivery system (sds) in the extension catheter, the stent became lost.In an attempt to remove the detached stent, a snare was advanced, but removing the stent was not successful.Another stent was then advanced to crush the lost stent and successfully complete the procedure.No patient complications resulted in relation to this event.It was later reported that the cause of the event was likely due to the complexity of the case, and that it was unknown which manufacturers stent was previously placed.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 Key10791267
MDR Text Key214750053
Report Number2134265-2020-15263
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 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/25/2020
Device Model Number10620
Device Catalogue Number10620
Device Lot Number0023740354
Was Device Available for Evaluation? No
Date Manufacturer Received11/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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