• 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 ELEMENT PLUS 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 ELEMENT PLUS STENT, CORONARY, DRUG-ELUTING Back to Search Results
Model Number 9384
Device Problem Human-Device Interface Problem
Event Date 08/29/2019
Event Type  Malfunction  
Manufacturer Narrative

Device is a combination product. A promus element plus, mr, ous 2. 25 x 16 mm stent delivery system was returned for analysis. A visual examination of the stent found evidence of distal stent damage with struts pulled distally over the distal marker-band. The undamaged crimped stent outer diameter was measured and the result is within maximum crimped stent profile measurement. The balloon cones were reviewed, and no issues were noted. The balloon wings were tightly wrapped and evenly folded and were not subjected to positive pressure. A visual and microscopic examination of the bumper tip showed no signs of damage. A visual and tactile examination of the hypotube found multiple kinks. A visual examination of the outer and inner lumen and mid-shaft section found no issues. No other issues were identified during the product analysis.

 
Event Description

Reportable based on device analysis completed on 19-nov-2019. It was reported that the wrong size stent was selected. A 2. 25x16mm promus element plus drug-eluting stent was advanced for treatment. However, it was noted that the physician had selected a size too small to treat the lesion and the device was removed. The procedure was completed with a different device. There were no patient complications nor injuries reported and the patient's status was stable. However, returned device analysis revealed stent damage.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePROMUS ELEMENT PLUS
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 Key9391972
Report Number2134265-2019-14621
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial
Report Date 11/29/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/29/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9384
Device Catalogue Number9384
Device LOT Number0022626440
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/24/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/19/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/03/2018
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-