• 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 CORONARY DRUG-ELUTING STENT

  • 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 CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Myocardial Infarction (1969)
Event Date 03/30/2021
Event Type  Injury  
Manufacturer Narrative
Journal article: proximal optimisation technique versus final kissing balloon inflation in coronary bifurcation lesions: the randomised, multicentre propot trial authors: watanabe, yusuke; murasato, yoshinobu; yamawaki, masahiro; kinoshita, yoshihisa; okubo, munenori; yumoto, kazuhiko; masuda, naoki; otake, hiromasa; aoki, jiro; nakazawa, gaku; numasawa, yohei; ito, tatsuya; shite, junya; okamura, takayuki; takagi, kensuke; kozuma, kayoko; lefvre, thierry; chevalier, bernard; louvard, yves; suzuki, nobuaki; kozuma, ken; watanabe, yusuke journal: eurointervention year: 2021 reference: 10. 4244/eij-d-20-01386. Age: average age, majority gender, date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
An article titled - proximal optimization technique versus final kissing balloon inflation in coronary bifurcation lesions: the randomized, multicenter propot trial - was submitted for review. The aim of the study was to investigate whether proximal optimization technique (pot) was superior in terms of stent apposition compared with the conventional kissing balloon technique (kbt) in real life bifurcation lesions using optical coherence tomography (oct). 120 patients were included in the prospective study and randomized into two groups for pci between april 2016 and july 2018. All patients had either a resolute integrity or a resolute onyx drug eluting stent implanted. The first group was the pot followed by side branch dilation group and included a final number of 57 patients. The final number of 58 patients of the second group underwent kbt. The primary endpoint of the study was the rate of malapposed struts assessed by the final oct. The rate of malapposed struts did not differ between the two groups. More additional treatments were required among the pot group. One year clinical outcomes included one myocardial infarction, clinically driven target lesion revascularization (tlr), main vessel in-stent restenosis, proximal edge re-stenosis and target vessel revascularization.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRESOLUTE INTEGRITY RX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
alison sweeney
parkmore business park west
galway 
EI  
091708096
MDR Report Key13650716
MDR Text Key287343439
Report Number9612164-2022-00845
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P110013
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/25/2022
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

Patient Treatment Data
Date Received: 03/02/2022 Patient Sequence Number: 1
-
-