• 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 BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM

  • 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 BIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Model Number 10604
Device Problem Obstruction of Flow (2423)
Patient Problems Chest Pain (1776); ST Segment Elevation (2059); Thrombosis (2100)
Event Date 05/27/2019
Event Type  Injury  
Manufacturer Narrative
Device is a combination product.
 
Event Description
It was reported that stent thrombosis and st-segment elevation occurred. The patient was given aspirin, plavix 300mg, tenecteplase (tnkase), heparin bolus and drip additional heparin given in central venous line. The target lesions were located in the proximal left anterior descending artery and mid circumflex artery. Subsequently, two synergy ii drug-eluting stents were implanted in the target lesions 95 and 112 minutes after tnkase. However, electrocardiogram showed st-segment elevation 5 hours after stent placement. The patient was sent back to lab and it was noted that both stents were occluded. The clot was removed, stents were placed and patient was given an integrilin and brilinta. Ejection fraction (ef) is 20-25% and no further chest pain was experienced prior to discharge follow-up clinic visit stated that patient is wearing a lifevest.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYNERGY
Type of DeviceBIODEGRADABLE POLYMER DRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
two scimed place
maple grove MN 55311
Manufacturer (Section G)
BOSTON SCIENTIFIC IRELAND LIMITED
ballybrit business park
galway
EI
Manufacturer Contact
jay johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key8749203
MDR Text Key149671719
Report Number2134265-2019-07044
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P150003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/01/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/05/2020
Device Model Number10604
Device Catalogue Number10604
Device Lot Number0022935283
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 Received07/01/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/06/2018
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: 07/01/2019 Patient Sequence Number: 1
-
-