• 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 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING

  • 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 PROMUS PREMIER STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9554
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802); ST Segment Elevation (2059); Thrombosis (2100); Cardiogenic Shock (2262)
Event Date 12/19/2020
Event Type  Death  
Event Description
It was reported that the patient died. The 70% stenosed, de novo target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery. After the lesion was pre-dilated with 2. 50mm x 15mm maverick balloon catheter, a 38 x 3. 50 promus premier drug-eluting stent was implanted. Following stent deployment, a 12mm x 4. 00mm nc quantum apex balloon catheter was advanced for post dilatation and the procedure was completed. However, several hours after the procedure, the patient developed cardiogenic shock with st elevation in avr, v1, v2, and v3. The following day, the patient experienced cardiac arrest and was connected to ventilator support. Despite of cardiopulmonary resuscitation and emergency medication, the patient died on december 16th. The physician believed that there might have acute thrombosis inside the implanted stent that resulted to the patient's death.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROMUS PREMIER
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
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 Key11131616
MDR Text Key225520263
Report Number2134265-2020-18553
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeBG
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date06/02/2022
Device Model Number9554
Device Catalogue Number9554
Device Lot Number0025567607
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 Received01/13/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2020
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: 01/07/2021 Patient Sequence Number: 1
-
-