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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 Obstruction of Flow (2423)
Patient Problems Atherosclerosis (1728); Reocclusion (1985); Thrombosis (2100); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Event Date 10/28/2020
Event Type  Injury  
Event Description
(b)(6) study.It was reported that in-stent restenosis occurred.In (b)(6) 2019, the subject was referred for cardiac catherization and on the same day index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 90% stenosis and was 35 mm long, with a reference vessel diameter of 3 mm.The target lesion was treated with pre-dilatation and placement of a 3.00x38mm synergy stent system the residual stenosis was 0%.Post dilation was not performed.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with 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.The following day, the subject was referred for coronary angiography which revealed 70% proximal to mid lad stenosis which was treated with drug balloon dilatation percutaneous coronary intervention - target vessel revascularization.Post intervention, residual stenosis was 0%.The following day, the subject was discharged on aspirin and clopidogrel.
 
Event Description
Synergy china registry clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2019, the subject was referred for cardiac catherization and on the same day index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 90% stenosis and was 35 mm long, with a reference vessel diameter of 3 mm.The target lesion was treated with pre-dilatation and placement of a 3.00x38mm synergy stent system the residual stenosis was 0%.Post dilation was not performed.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with 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.The following day, the subject was referred for coronary angiography which revealed 70% proximal to mid lad stenosis which was treated with drug balloon dilatation percutaneous coronary intervention - target vessel revascularization.Post intervention, residual stenosis was 0%.The following day, the subject was discharged on aspirin and clopidogrel.It was further reported that the event was classified as stent thrombosis.
 
Event Description
Synergy china registry clinical study.It was reported that in-stent restenosis occurred.In (b)(6) 2019, the subject was referred for cardiac catherization and on the same day index procedure was performed.The target lesion was located in the proximal left anterior descending artery (lad) extended to mid lad with 90% stenosis and was 35 mm long, with a reference vessel diameter of 3 mm.The target lesion was treated with pre-dilatation and placement of a 3.00x38mm synergy stent system the residual stenosis was 0%.Post dilation was not performed.The following day, the subject was discharged on aspirin and clopidogrel.In (b)(6) 2020, the subject presented with 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.The following day, the subject was referred for coronary angiography which revealed 70% proximal to mid lad stenosis which was treated with drug balloon dilatation percutaneous coronary intervention - target vessel revascularization.Post intervention, residual stenosis was 0%.The following day, the subject was discharged on aspirin and clopidogrel.It was further reported that the event was classified as stent thrombosis.It was further reported that stent thrombosis did not occur and the event should have remained as the in-stent restenosis originally reported.The event was considered to be recovering/resolving.
 
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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 Key10932034
MDR Text Key219129009
Report Number2134265-2020-16765
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 04/14/2021
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 Expiration Date09/15/2020
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0023575184
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/17/2020
Initial Date FDA Received12/02/2020
Supplement Dates Manufacturer Received12/31/2020
04/01/2021
Supplement Dates FDA Received01/11/2021
04/14/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age50 YR
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