• 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 9551
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)
Event Date 08/18/2020
Event Type  Injury  
Event Description
Promus premier (b)(6) registry. It was reported that coronary atherosclerotic heart disease occurred. In (b)(6) 2019, the subject presented with stable angina and was referred for cardiac catheterization. The target lesion was located in the proximal left anterior descending (lad) artery extending up to distal lad with 100% stenosis and was 77 mm long, with a reference vessel diameter of 2. 75mm. The target lesion was treated with pre-dilatation and placement of 2. 75 mm x 24 mm and 3. 00 mm x 28 mm study stents. Following post-dilatation, the residual stenosis was 0%. Two days later, the subject was discharged on aspirin and ticagrelor. In (b)(6) 2020, the subject presented with cardiac related symptoms and was hospitalized for further evaluation. Five days later, the subject was diagnosed with coronary heart disease. The subject was referred for coronary angiography which revealed 80% distal stenosis in lad and was treated with percutaneous transluminal coronary angiography (ptca). Post intervention, residual stenosis was 0%. On the following day, the event was considered to be recovered and resolved and on the same day, the subject was discharged.
 
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 Key12094281
MDR Text Key259222673
Report Number2134265-2021-08318
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
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
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date10/31/2020
Device Model Number9551
Device Catalogue Number9551
Device Lot Number0022929380
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 Received06/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/01/2018
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: 06/30/2021 Patient Sequence Number: 1
-
-