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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 Problem Fracture (1260)
Patient Problems No Consequences Or Impact To Patient (2199); Insufficient Information (4580)
Event Date 01/01/2021
Event Type  Injury  
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 stent fracture occurred.A synergy ii drug-eluting stent was advanced for treatment.However, after being deployed under cine views, the physician felt that the stent was fractured.No complications were reported.No further information available.
 
Event Description
It was reported that stent fracture occurred.A synergy ii drug-eluting stent was advanced for treatment.However, after being deployed under cine views, the physician felt that the stent was fractured.No complications were reported.No further information available.It was further reported that the target lesion was moderately tortuous, non-calcified, and located in the middle / proximal left anterior descending artery.The vessel preparation was believed to be appropriate.The proximal/mid section of the stent itself was fractured.There was "gapping" noted upon placement of stent and felt that the flow was not adequate through stent in the same area.A second stent was placed and post dilated to 4.5 mm.The patient passed away two weeks after the procedure.
 
Manufacturer Narrative
B3: date of event: approximated to on (b)(6) 2021 as the reported date is around the first week on (b)(6) 2021.B2: outcomes attrib to adv event: updated to death from other serious (important medical events).B2: date of death: two weeks after the procedure.B5: describe event or problem updated.
 
Manufacturer Narrative
B3 - date of event: approximated to (b)(6) 2021 as the reported date is around the first week of (b)(6) 2021.B2 - outcomes attrib to adv event: updated to death from other serious (important medical events).B2 - date of death: two weeks after the procedure.B5 - describe event or problem updated.Device evaluated by mfr.: the device was not returned for analysis.However, procedural media was received and reviewed.Target lesion in proximal left anterior descending artery treated with synergy stent.Stent cell disruption appeared likely after post-dilation.Opening of stent side cells, straightening of the crowns or zig-zag struts may occur with aggressive overexpansion.Stent cell disruption was resolved with implantation of an overlapping stent.The images provided are consistent with stent damage.Stent cell opening or crown straightening can lead to inconsistent vessel coverage as demonstrated in the images.The images do not show evidence of discontinuity consistent with stent fracture.H3 other text : procedural media.
 
Event Description
It was reported that stent fracture occurred.A synergy ii drug-eluting stent was advanced for treatment.However, after being deployed under cine views, the physician felt that the stent was fractured.No complications were reported.No further information available.It was further reported that the target lesion was moderately tortuous, non-calcified, and located in the middle/proximal left anterior descending artery.The vessel preparation was believed to be appropriate.The proximal/mid section of the stent itself was fractured.There was "gapping" noted upon placement of stent and felt that the flow was not adequate through stent in the same area.A second stent was placed and post dilated to 4.5 mm.The patient passed away two weeks after the procedure.
 
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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 Key11240003
MDR Text Key229089275
Report Number2134265-2021-00437
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,health
Type of Report Initial,Followup,Followup
Report Date 03/23/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/27/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2021
Date Manufacturer Received03/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death; Other;
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