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

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.

• Brand Name: RESOLUTE INTEGRITY 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: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13650716
• MDR Text Key: 287343439
• Report Number: 9612164-2022-00845
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• 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 Received: 03/02/2022
• 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 Received: 04/25/2022
• 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