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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.
 
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Brand NameSYNERGY
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key10932034
MDR Text Key219129009
Report Number2134265-2020-16765
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
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
Date FDA Received12/02/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/15/2020
Device Model Number10623
Device Catalogue Number10623
Device Lot Number0023575184
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/01/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/20/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/02/2020 Patient Sequence Number: 1
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