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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC IRELAND ENDEAVOR RESOLUTE RX CORONARY DRUG-ELUTING STENT

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MEDTRONIC IRELAND ENDEAVOR RESOLUTE RX CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/06/2019
Event Type  malfunction  
Manufacturer Narrative
Please note that this device is not marketed in the united states; however, it is similar to the united states marketed device endeavor rx coronary drug eluting stent. This event is being reported only as a malfunction because of the similar device requirement in 803 which is limited to malfunctions. Journal article: incidence, predictors, and outcomes of distal vessel expansion on follow-up intravascular ultrasound after recanalization of chronic total occlusions using new-generation drug-eluting stents: data from the cto-ivus randomized trial authors: sung-jin hong, byeong-keuk kim, young-joo kim, seung-woon rha, seung-jin lee, hee-yeol kim, jin-ho choi, chul-min ahn, jung-sun kim, young-guk ko, doonghoon choi, myeong-ki hong, yangsoo jang journal: catheter cardiovascular interventions year: 2020 reference: doi: 10. 1002/ccd. 28461. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article titled - incidence, predictors, and outcomes of distal vessel expansion on follow-up intravascular ultrasound after recanalization of chronic total occlusions using new-generation drug-eluting stents: data from the cto-ivus randomized trial - was submitted for review. This study aimed to evaluate the incidence, predictors, and outcomes of distal vessel expansion on intravascular ultrasound (ivus) after recanalization of chronic total occlusion (cto) particularly using new-generation drug-eluting stent (des). Medtronic endeavor resolute coronary des was among the devices used. The primary outcome was the predictors of distal vesselexpansion (any increase of lumen area at the distal reference) on 1-year follow-up ivus and this was evaluated by multivariable binary logistic analyses. The secondary outcome was to assess clinical outcomes according to the presence or absence of distal vessel expansion. A total of 69 new-generation des-treated ctos with serial matched ivus analyses at index percutaneous coronary intervention (pci) were included in this study. Among the 69 included patients, 39 (57%) received an endeavor resolute des. After opening the cto using a new-generation des, two-thirds of patients exhibited distal vessel expansion on ivus at 1-year follow up. The rate of the persistent distal edge dissection was identical in both groups, while the rates of incomplete stent apposition, including the occurrence of late-acquired malapposition, showed no significant differences between the groups. During a median follow-up period of 5. 1 years after the index pci, target vessel revascularizations were required in two patients in the distal vessel-expanded group and one patient in the non-expanded group.
 
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Brand NameENDEAVOR RESOLUTE 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
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key12015334
MDR Text Key262198500
Report Number9612164-2021-02354
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeKS
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
Report Date 06/17/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received06/10/2021
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

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