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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 10606
Device Problem Obstruction of Flow (2423)
Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 05/27/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent thrombosis and st-segment elevation occurred.The patient was given aspirin, plavix 300mg, tenecteplase (tnkase), heparin bolus and drip additional heparin given in central venous line.The target lesions were located in the proximal left anterior descending artery and mid circumflex artery.Subsequently, two synergy ii drug-eluting stents were implanted in the target lesions 95 and 112 minutes after tnkase.However, electrocardiogram showed st-segment elevation 5 hours after stent placement.The patient was sent back to lab and it was noted that both stents were occluded.The clot was removed, stents were placed and patient was given an integrilin and brilinta.Ejection fraction (ef) is 20-25% and no further chest pain was experienced prior to discharge.Follow-up clinic visit stated that patient is wearing a lifevest.
 
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent thrombosis and st-segment elevation occurred.The patient was given aspirin, plavix 300mg, tenecteplase (tnkase), heparin bolus and drip additional heparin given in central venous line.The target lesions were located in the proximal left anterior descending artery and mid circumflex artery.Subsequently, two synergy ii drug-eluting stents were implanted in the target lesions 95 and 112 minutes after tnkase.However, electrocardiogram showed st-segment elevation 5 hours after stent placement.The patient was sent back to lab and it was noted that both stents were occluded.The clot was removed, stents were placed and patient was given an integrilin and brilinta.Ejection fraction (ef) is 20-25% and no further chest pain was experienced prior to discharge.Follow-up clinic visit stated that patient is wearing a lifevest.It was further reported that the patient also experienced chest pain post stent placement.
 
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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 Key8749202
MDR Text Key149670433
Report Number2134265-2019-07037
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08714729840336
UDI-Public08714729840336
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 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date12/02/2020
Device Model Number10606
Device Catalogue Number10606
Device Lot Number0023082410
Was Device Available for Evaluation? No
Date Manufacturer Received07/01/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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