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

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/30/2015

Event Type  malfunction  

Manufacturer Narrative

Journal article: impacts of lesion angle on incidence and distribution of acute vessel wall injuries and strut malapposition after drug-eluting stent implantation assessed by optical coherence tomography authors: yoshiyasu minami, daniel s.Ong, shiro uemura, zhao wang, aaron d.Aguirre, shankha mukhopadhyay, tsunenari soeda, rocco vergallo, haibo jia, jinwei tian, sining hu, soo joong kim, chang-bum park, harold l.Dauerman, stephen lee, and ik-kyung jang journal: european heart journal ¿ cardiovascular imaging year: 2015 reference: doi:10.1093/ehjci/jev108.Patient deaths were also included in the results of the journal article, however no causal link suggesting that the medtronic devices used in the patient cohort may have caused or contributed to the deaths was provided.Age or date of birth: average age, sex: majority gender, date of event: date of publication.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article titled - impacts of lesion angle on incidence and distribution of acute vessel wall injuries and strut malapposition after drug-eluting stent implantation assessed by optical coherence tomography - was submitted for review.The aim of this study was to investigate the impact of lesion angle on the incidence and distribution of acute vessel wall injuries, and incomplete stent apposition (isa) following second-generation drug-eluting stent (des) implantation using optical coherence tomography (oct).The qualitative analysis included edge dissection, in stent dissection, thrombus, isa, and tissue protrusion.Major adverse cardiac event (mace) was defined as the composite of cardiac death, myocardial infarction, stent thrombosis, and target lesion revascularization (tlr).Tlr and target vessel revascularization were defined as any revascularization procedure of the target lesion and the target vessel, respectively.A total of 243 lesions treated with a single des were included in the study, with 95 of these being treated with the medtronic resolute integrity drug-eluting stent.All lesions were classified into an angled group of = 45° or non angled group <45°.The vessel wall injuries and isa were evaluated by a non-medtronic oct.The incidence of in-stent dissection, thrombus, and isa was significantly higher in the angled group than in the non-angled group.The incidence of edge dissection and tissue protrusion was comparable between the two groups.The normalized volume of thrombus, the percentage of malapposed struts, and the maximum malapposed distance were also comparable between the two groups.The incidence of major adverse cardiac events within 12 months was similar between the groups.

Manufacturer Narrative

Additional information: annex d code added.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: CORONARY DRUG-ELUTING STENT
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; EI
• MDR Report Key: 12511633
• MDR Text Key: 272661422
• Report Number: 9612164-2021-03643
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/01/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR