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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
Model Number 10600
Device Problems Material Deformation (2976); Migration (4003)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 12/27/2018
Event Type  Injury  
Manufacturer Narrative
Device is combination product.
 
Event Description
It was reported that stent damage and migration occurred.The patient presented with coronary artery disease in both the left anterior descending artery (lad) and the left circumflex (lcx).Both vessels were wired.The proximal lad was then pre dilated with an emerge balloon.The proximal circumflex was also pre dilated with an emerge balloon.The 2.75mm x 8mm synergy stent was then placed in the ostial lcx.An emerge balloon was present but not inflated in the ostial lad at this point.The stent was then successfully deployed.The stent covered the entire ostium of the first obtuse marginal branch (om) and was an easy reference point to use.An nc emerge balloon was placed in the lad to crush the proximal portion of the stent in a common bifurcation stent practice.However, the physician believes this causes the proximal portion of the stent to collapse in on itself and also caused the stent to move further distal down the vessel.He used the ostium of the first om as a reference point to know the stent had moved distal down the vessel.Now the proximal portion of the stent had an extremely narrow opening.A 1.5mm emerge balloon was inflated to enlarge the proximal stent opening.Another emerge was then used to dilate both the proximal lcx (inside the stent) and the proximal lad.Two new stents had to be placed in the proximal lad and the lcx.The stents were inflated simultaneously in a kiss technique.An nc balloon was also used to post dilate both the lad and the lcx.The end result was good and no harm came to the patient.
 
Event Description
It was reported that stent damage and migration occurred.The patient presented with coronary artery disease in both the left anterior descending artery (lad) and the left circumflex (lcx).Both vessels were wired.The proximal lad was then pre dilated with an emerge balloon.The proximal circumflex was also pre dilated with an emerge balloon.The 2.75mm x 8mm synergy stent was then placed in the ostial lcx.An emerge balloon was present but not inflated in the ostial lad at this point.The stent was then successfully deployed.The stent covered the entire ostium of the first obtuse marginal branch (om) and was an easy reference point to use.An nc emerge balloon was placed in the lad to crush the proximal portion of the stent in a common bifurcation stent practice.However, the physician believes this causes the proximal portion of the stent to collapse in on itself and also caused the stent to move further distal down the vessel.He used the ostium of the first om as a reference point to know the stent had moved distal down the vessel.Now the proximal portion of the stent had an extremely narrow opening.A 1.5mm emerge balloon was inflated to enlarge the proximal stent opening.Another emerge was then used to dilate both the proximal lcx (inside the stent) and the proximal lad.Two new stents had to be placed in the proximal lad and the lcx.The stents were inflated simultaneously in a kiss technique.An nc balloon was also used to post dilate both the lad and the lcx.The end result was good and no harm came to the patient.It was further reported that the target lesion was >70% stenosed and was moderately tortuous.There was no attempt to remove the stent.Once the physician believed the stent to have moved after a balloon inflation in the proximal lad, he was able to change the stenting strategy to overlap the previously deployed stent with a second stent that was able to cover the lesion.
 
Manufacturer Narrative
Device is combination product.
 
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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 Key8282335
MDR Text Key134245434
Report Number2134265-2019-00451
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/20/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number10600
Device Catalogue Number10600
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/07/2019
Initial Date FDA Received01/28/2019
Supplement Dates Manufacturer Received01/29/2019
Supplement Dates FDA Received02/20/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age75 YR
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