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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 10621
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Event Date 05/05/2020
Event Type  Injury  
Event Description
(b)(6) registry it was reported that coronary atherosclerotic heart disease and restenosis occurred. In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization. The index procedure was performed on the same day. The target lesion 1 was located in the proximal left anterior descending artery (lad) extending up to mid lad with 70 % stenosis and was 47 mm long, with a reference vessel diameter of 2. 75mm. The target lesion was treated with pre-dilatation and placement of 2. 50mmx 28 mm stent overlapped with another 2. 75 mm x 24 mm synergy stent system. Post-dilatation was performed with 0% residual stenosis. The target lesion 2 was located in the mid left circumflex artery (lcx) with 90% stenosis and was 25mm long, with a reference vessel diameter of 2. 75mm. The target lesion was treated with pre-dilatation and placement of 2. 75 mm x 28 mm synergy stent system. Post-dilatation was performed with 0% residual stenosis. Four days later, the subject was discharged on aspirin, clopidogrel and ticagrelor. In (b)(6) 2020, the subject was diagnosed with coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment. On the following day, the subject was referred for coronary angiography which revealed 85% proximal stenosis in lcx extending up to distal lcx which had previously placed study device. The stenosis was treated with percutaneous coronary intervention (pci) and target-vessel revascularization (tvr). Post intervention, residual stenosis was 0%. Non-target vessel revascularization was also performed. At the time of reporting, the event was considered recovering/resolving. Two days later, the subject was discharged.
 
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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 Key11810076
MDR Text Key250181311
Report Number2134265-2021-05958
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
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
Report Date 10/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date05/24/2020
Device Model Number10621
Device Catalogue Number10621
Device Lot Number0023017624
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 Received09/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/26/2018
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: 05/11/2021 Patient Sequence Number: 1
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