• 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 9550
Device Problems Fracture; Device Damaged by Another Device
Event Date 09/19/2019
Event Type  Injury  
Manufacturer Narrative

Device is a combination product.

 
Event Description

It was reported that the patient experienced discomfort and stent fracture occurred. The severely stenosed target lesion was tortuous and calcified. A 20 x 3. 00 promus premier drug-eluting stent was deployed to treat the lesion. Following the initial procedure, the patient felt discomfort. On the second procedure, the implanted stent was found fractured. Since the fractured stent could not be removed, a non-bsc stent was then deployed to cover the fractured stent. No further complications were reported and the patient's status was stable.

 
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 johnson
two scimed place
maple grove , MN 55311
7634942574
MDR Report Key9186140
Report Number2134265-2019-12143
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,DISTRI
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/13/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/14/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number9550
Device Catalogue Number9550
Device LOT Number0022502805
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/21/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/19/2019
Was Device Evaluated By Manufacturer? No
Date Device Manufactured08/08/2018
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: 10/14/2019 Patient Sequence Number: 1
-
-