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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 10619
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Complaint, Ill-Defined (2331); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Event Date 09/08/2020
Event Type  Injury  
Event Description
(b)(6) study. It was reported that cardiac related symptoms and coronary atherosclerotic heart disease occurred. In (b)(6) 2019, the subject was referred for cardiac catheterization and the index procedure was performed on the same day. The target lesion #1 was located in the mid left anterior descending artery (lad) extending up to distal lad with 99% stenosis and was 38 mm long, with a reference vessel diameter of 3. 0 mm. The target lesion was treated with pre-dilatation and placement of 3. 0 mm x 38 mm synergy stent system. Following post-dilatation, the residual stenosis was 0%. After three days, staged procedure was performed. The target lesion #1 was located in the proximal right coronary artery (rca) extending up to distal rca with 99% stenosis and was 84 mm long, with a reference vessel diameter of 3. 5 mm. The target lesion was treated with pre-dilatation and placement of 2. 75 mm x 32 mm, 3. 50 mm x 32 mm and 3. 50 mm x 20 mm synergy stent system. Following post-dilatation, the residual stenosis was 0%. Target lesion #2 was located in the mid left circumflex (lcx) artery with 90% stenosis and was 38 mm long, with a reference vessel diameter of 3. 0 mm. The target lesion was treated with pre-dilatation and placement of 3. 0 mm x 38 mm synergy stent system. Three days post procedure, the subject was discharged on aspirin and other medications. In (b)(6) 2020, the subject presented with cardiac related symptoms and was hospitalized on the same day for further analysis. Diagnostics revealed coronary atherosclerotic heart disease. Medication was given and non- target vessel revascularization(tvr) was performed to treat the event. The following day, the event was considered recovered/resolved and 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 Key10796583
MDR Text Key215044739
Report Number2134265-2020-15428
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
Report Date 04/05/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/05/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/25/2020
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0023764305
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 Received03/26/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/29/2019
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: 11/05/2020 Patient Sequence Number: 1
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