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

Device Problem Activation, Positioning or Separation Problem (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.

• Brand Name: ENDEAVOR RESOLUTE RX
• Type of Device: CORONARY 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 Key: 12015334
• MDR Text Key: 262198500
• Report Number: 9612164-2021-02354
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2021
• Initial Date FDA Received: 06/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 59 YR