Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 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
 

SYNERGY; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 10619
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Angina (1710)
Event Date 08/16/2022
Event Type  Injury  
Event Description
Synergy china registry.It was reported that stable angina occurred.In (b)(6) 2020, the subject presented with unstable angina and was referred for cardiac catheterization.The target lesion was located in the left main coronary artery (lmca) extending up to proximal left anterior descending artery (lad) with 99% stenosis and was 15 mm long, with a reference vessel diameter of 3.00 mm.The target lesion was treated with pre-dilatation and placement of a 3.00 mm x 20 mm synergy stent system.Following post-dilatation, the residual stenosis was noted to be 0%.Two days later, the subject was discharged on aspirin and ticagrelor.In (b)(6) 2022, the subject was diagnosed with stable angina pectoris.Medication was given to treat the event.At the time of reporting the event was considered to be not recovered/ not resolved.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYNERGY
Type of Device
CORONARY DRUG-ELUTING STENT
MDR Report Key18717533
MDR Text Key335521688
Report Number2124215-2024-08533
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Study,Health Professional,Company Representative
Type of Report Initial
Report Date 02/15/2024
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? No
Device Operator Health Professional
Device Expiration Date12/07/2020
Device Model Number10619
Device Catalogue Number10619
Device Lot Number0023976115
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/29/2024
Initial Date FDA Received02/15/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/11/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age71 YR
Patient SexFemale
-
-