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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 Problem Difficult to Remove (1528)
Patient Problems Death (1802); Obstruction/Occlusion (2422)
Event Date 11/01/2020
Event Type  Death  
Manufacturer Narrative
Date of death and date of event: the dates were estimated as the specific dates are unknown.
 
Event Description
It was reported removal difficulties and death occurred.A percutaneous coronary intervention was being performed.A synergy drug eluting stent was deployed in the patient.During removal, there was resistance withdrawing the balloon from the stent.The guide catheter was then "sucked in" as the balloon was attempted to be withdrawn, blocking coronary blood flow.The patient ultimately passed away.Boston scientific is continuing to follow up for additional information.
 
Event Description
It was reported removal difficulties and death occurred.A percutaneous coronary intervention was being performed.A synergy drug eluting stent was deployed in the patient.During removal, there was resistance withdrawing the balloon from the stent.The guide catheter was then "sucked in" as the balloon was attempted to be withdrawn, blocking coronary blood flow.The patient ultimately passed away.Boston scientific is continuing to follow up for additional information.It was further reported that a syngery ii stent, with a 24mm length, was deployed in the left anterior descending artery (lad).It was noted that the guide catheter used during the procedure was likely a 6fr or 7fr non boston scientific (bsc) device.The balloon catheter of the synergy met resistance when the device was pulled back and reached the non bsc guide catheter.It was noted that the non bsc guide catheter began to suck inward.There was a struggle to remove the balloon catheter and the flow became blocked.It was noted that because this was in the lad, the patient likely did not get sufficient blood flow, which led to ischemia of the anterior wall.The patient ultimately fibrillated leading to a lethal rhythm and the patient expired.
 
Manufacturer Narrative
B2 date of death and b3 date of event: the dates were estimated as the specific dates are unknown.
 
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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 Key11023752
MDR Text Key221939078
Report Number2134265-2020-18033
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
Report Date 01/06/2021
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 11/17/2020
Initial Date FDA Received12/16/2020
Supplement Dates Manufacturer Received12/18/2020
Supplement Dates FDA Received01/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
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