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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 10623
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atherosclerosis (1728); Thrombosis (2100); Complaint, Ill-Defined (2331)
Event Date 08/29/2020
Event Type  Injury  
Event Description
(b)(6) clinical study.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 80% stenosis and was 51 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.An additional drug eluting stent was implanted to cover the lesion length.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with unknown symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.Angiography without revascularization was performed during the event and at the time of reporting, the event was considered recovering/resolving.Four days later, the subject was discharged on aspirin and clopidogrel.
 
Event Description
Synergy china registry clinical study.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 80% stenosis and was 51 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.An additional drug eluting stent was implanted to cover the lesion length.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with unknown symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.Angiography without revascularization was performed during the event and at the time of reporting, the event was considered recovering/resolving.Four days later, the subject was discharged on aspirin and clopidogrel.It was further reported that in (b)(6) 2020, angiography was performed which revealed 20% stenosis in the proximal lad which is lesion treated during index procedure and the subject was diagnosed with stent thrombosis.
 
Event Description
Synergy china registry clinical study it was reported that coronary atherosclerotic heart disease and stent thrombosis occurred.In october 2019, the index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 80% stenosis and was 51 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 x 38 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.An additional drug eluting stent was implanted to cover the lesion length.The following day, the subject was discharged on aspirin and clopidogrel.In august 2020, the subject presented with unknown symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.Angiography without revascularization was performed during the event and at the time of reporting, the event was considered recovering/resolving.Four days later, the subject was discharged on aspirin and clopidogrel.It was further reported that in august 2020, angiography was performed which revealed 20% stenosis in the proximal lad which is lesion treated during index procedure and the subject was diagnosed with stent thrombosis.It was further reported that the event did not qualify for stent thrombosis per clinical events committee (cec).Therefore, the diagnosis of stent thrombosis was removed.
 
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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 Key10819338
MDR Text Key215610201
Report Number2134265-2020-15635
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,Followup
Report Date 01/11/2021
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? No
Device Operator Health Professional
Device Expiration Date07/19/2020
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0023242482
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/27/2020
Initial Date FDA Received11/10/2020
Supplement Dates Manufacturer Received11/23/2020
12/31/2020
Supplement Dates FDA Received12/10/2020
01/11/2021
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Other;
Patient Age61 YR
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