• 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 ELITE 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 ELITE STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 10671
Device Problem Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/28/2020
Event Type  Malfunction  
Event Description

It was reported a stent had fractured. Vascular access was obtained via the right femoral artery. The 4. 5 x 10mm, concentric, de novo target lesion was located in the mildly tortuous and moderately calcified left main (lm) artery. The physician used a 6f jl 3. 5guide catheter and engaged coaxially. Then the left anterior descending (lad) artery was wired with a runthrough ns. The lad was predilated with a 2. 75 x 12 sapphire balloon, after which, stenosis was 40%. A 2. 5 x 28 promus premier select drug-eluting stent was maneuvered and deployed in the mid lad. After, post-dilation was performed with the sapphire balloon. The same sapphire balloon was used to predilate the lm. A 4. 00 x 12 promus elite drug-eluting stent and deployed in the lm and was post dilated with a 4. 5 x 8 mm sapphire balloon to 12 atm. After withdrawal, the physician noted that the stent was fractured in the lm ostium. A 4. 5 x 12 mm resolute onyx stent was deployed at 12 atm within the fractured stent to complete the procedure. No further patient complications were reported and the patient status was stable.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROMUS ELITE
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 Key10546332
MDR Text Key207335019
Report Number2134265-2020-12902
Device Sequence Number1
Product Code NIQ
Combination Product (Y/N)N
Reporter Country CodeIN
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 09/17/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/17/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number10671
Device Catalogue Number10671
Device LOT Number0023829375
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 Received08/28/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured05/15/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-