• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION SYNERGY CORONARY DRUG-ELUTING STENT

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Atherosclerosis (1728); Complaint, Ill-Defined (2331); Arteriosclerosis/ Atherosclerosis (4437)
Event Date 11/18/2020
Event Type  Injury  
Event Description
(b)(6) registry. It was reported that the subject experienced symptoms of coronary atherosclerotic heart disease. In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization. The index procedure was performed and the target lesion was located in the mid left anterior descending artery (lad) with 90% stenosis and was 19 mm long, with a reference vessel diameter of 3 mm. The target lesion was treated with pre-dilatation and placement of a 3. 0 x 20 mm synergy china stent system. Following post-dilatation, the residual stenosis was 0%. Myocardial enzyme elevation was also confirmed. Two days later, the subject was discharged on aspirin and other antiplatelet medications. In (b)(6) 2020, the subject presented with symptoms of coronary atherosclerotic heart disease and was hospitalized on the same day for further evaluation and treatment. Subject was diagnosed with coronary atherosclerotic heart disease and coronary angiography was recommended. At the time of reporting, the event was considered recovering/resolving. Two days later, the subject was discharged on aspirin and other antiplatelet medications. No other information is available at this point of time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11023073
MDR Text Key221868620
Report Number2134265-2020-18021
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 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/16/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/26/2020
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0023299302
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 Received02/05/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/28/2019
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: 12/16/2020 Patient Sequence Number: 1
-
-