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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 10622
Device Problems Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Atherosclerosis (1728); Reocclusion (1985); Complaint, Ill-Defined (2331); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Event Date 08/19/2020
Event Type  Injury  
Event Description
(b)(6) registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.
 
Event Description
Synergy china registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).
 
Event Description
Synergy china registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).It was further reported that balloon dilatation performed was considered target vessel revascularization (tvr).It was further reported that in (b)(6) 2020, 85% stenosis noted in proximal rca extending up to middle rca which previously had the study device was treated with percutaneous coronary intervention (pci).Post intervention, residual stenosis was 0%.
 
Event Description
Synergy china registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6)2020, the subject presented with symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).It was further reported that balloon dilatation performed was considered target vessel revascularization (tvr).
 
Manufacturer Narrative
H6: codes corrected from fda codes to imdrf codes.
 
Event Description
Synergy china registry clinical.It was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In (b)(6) 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).It was further reported that balloon dilatation performed was considered target vessel revascularization (tvr).It was further reported that in (b)(6) 2020, 85% stenosis noted in proximal rca extending up to middle rca which previously had the study device was treated with percutaneous coronary intervention (pci).Post intervention, residual stenosis was 0%.
 
Manufacturer Narrative
B5 - describe event or problem has been updated.B7 - other relevant history has been updated.Corrections: h6: codes corrected from fda codes to imdrf codes.
 
Event Description
Synergy china registry clinical it was reported that the subject experienced symptoms related to coronary atherosclerotic heart disease.In october 2019, the subject presented with unstable angina.The subject was referred for cardiac catheterization and on the same day, the index procedure was performed.The target lesion was located in the middle right coronary artery (rca) extended to middle rca with 80% stenosis and was 29 mm long, with a reference vessel diameter of 2.50 mm.The lesion was treated with pre-dilatation and placement of a 2.50 x 32 mm synergy stent system.Following post-dilatation, the residual stenosis was 0%.Two days later, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with symptoms related to coronary heart disease and was hospitalized for further evaluation and treatment.The subject was diagnosed with coronary atherosclerotic heart disease.The event was treated with balloon dilatation and at the time of reporting, the event was considered recovering/resolving.It was further reported that in (b)(6) 2020, the balloon dilatation performed was considered non-target vessel revascularization (non-tvr).It was further reported that balloon dilatation performed was considered target vessel revascularization (tvr).It was further reported that in (b)(6) 2020, 85% stenosis noted in proximal rca extending up to middle rca which previously had the study device was treated with percutaneous coronary intervention (pci).Post intervention, residual stenosis was 0%.It was further reported that in october 2019, the mid left circumflex (lcx) artery extending up to distal lcx (non-tvr) was also treated.Furthermore, in august 2020, the rationale of intervention was angina and symptoms of ischemia and the subject was discharged on aspirin and clopidogrel.
 
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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 Key10817455
MDR Text Key215537074
Report Number2134265-2020-15616
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,Followup,Followup
Report Date 09/30/2021
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 Date08/02/2020
Device Model Number10622
Device Catalogue Number10622
Device Lot Number0023325130
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
01/18/2021
01/18/2021
09/16/2021
Supplement Dates FDA Received12/16/2020
01/13/2021
02/02/2021
02/03/2021
09/30/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age62 YR
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