• 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 10622
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); Aortic Dissection (2491); Pericardial Effusion (3271)
Event Date 10/28/2019
Event Type  Death  
Manufacturer Narrative
Device is a combination product.
 
Event Description
(b)(6) registry. It was reported that the patient died. In (b)(6) 2019, index procedure was performed. The subject was on prior regimen of p2y12 inhibitors and received heparin medication. The subject did not receive any loading doses of antiplatelet medication. The target lesion was located in the mid left circumflex artery (lcx) extending to distal lcx with 90% stenosis and was 32 mm long, with a reference vessel diameter of 3. 5 mm. The target lesion was treated with pre-dilatation and placement of a 3. 5 x 32 mm study stent. Post-dilatation performed with 0% residual stenosis. Five days later, the subject was discharged on clopidogrel. Subsequently, the subject was diagnosed with rupture of aorta due to dissection and pericardial tamponade. The event was initially medically treated. The subject became unconscious in the early morning. Ct examination of the head and chest showed that the possibility of aortic dissection and pericardial effusion were considered. While preparing for the ct scan, the patient suddenly suffered respiratory and cardiac arrest, and died despite rescue efforts. Autopsy was not performed.
 
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 johnson
two scimed place
maple grove, MN 55311
7634942574
MDR Report Key9825411
MDR Text Key183159160
Report Number2134265-2020-02681
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 03/20/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/07/2020
Device Model Number10622
Device Catalogue Number10622
Device Lot Number0023097886
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 Received03/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured12/10/2018
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: 03/12/2020 Patient Sequence Number: 1
-
-