• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND RESOLUTE INTEGRITY RX 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
 

MEDTRONIC IRELAND RESOLUTE INTEGRITY RX STENT, CORONARY, DRUG-ELUTING Back to Search Results
Lot Number UNKNOWN
Device Problems Fracture; Activation, Positioning or SeparationProblem
Event Date 08/30/2018
Event Type  Malfunction  
Manufacturer Narrative

A2=average age a3= majority gender b3=date of publication optical coherence tomography predictors for recurrent restenosis after paclitaxel-coated balloon angioplasty for drug-eluting stent restenosis. Doi: 10. 1253/circj. Cj-18-0464. If information is provided in the future, a supplemental report will be issued.

 
Event Description

548 drug-eluting stent (des) in-stent restenosis (isr) lesions were exclusively treated with pcb angioplasty for the first time between (b)(6)2008 and (b)(6) 2016. Medtronic zotarolimus and resolute zotarolimus-eluting stents were among the des that exhibited restenosis. Lesions treated included the left main, lad, left circumflex and right. This study investigated the association between oct findings and mid-term angiographic outcomes. The main findings of the study were: (1) the heterogeneous pattern was associated with recurrent restenosis at follow-up; (2) smaller post-procedural mla, caused primarily by persistent stent underexpansion, was also a main cause of recurrent restenosis; and (3) previous stent fracture, heterogeneous pattern, and stent underexpansion were independent risk factors for recurrent restenosis.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESOLUTE INTEGRITY RX
Type of DeviceSTENT, CORONARY, DRUG-ELUTING
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
Manufacturer Contact
toni o'doherty
parkmore business park west
galway  
091708734
MDR Report Key8225796
Report Number9612164-2019-00096
Device Sequence Number1
Product CodeNIQ
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial
Report Date 01/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device LOT NumberUNKNOWN
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 Received12/10/2018
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-