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

Device Problem Activation, Positioning or Separation Problem (2906)

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

Event Date 03/07/2020

Event Type  malfunction  

Manufacturer Narrative

Journal article: efficacy of zotarolimus-eluting stents in treating diabetic coronary lesions: an optical coherance tomography study authors: zhengbin zhu, jinzhou zhu, run du, haotian zhang, jinwei nid journal: advances in therapy year: 2020 ref: doi.Org/10.6084/m9.Figshare.11871414.If information is provided in the future, a supplemental report will be issued.

Event Description

This study was a single-center subgroup data analysis of the resolute dm (diabetes mellitus)-china study.The study using optical coherence tomography (oct) aimed to compare target lesion neointima in patients with or without diabetes after zotarolimus-eluting stent (zes) treatment.Oct images of 90,212 struts and quantitative coronary angiography (qca) in 62 patients (32 with dm and 30 without dm) with 69 de novo coronary lesions (34 dm and 35 non-dm) both after zes implantation and at 12 month angiographic follow-up were recorded.Resolute zotarolimus-eluting stents were implanted in all patients enrolled in this study.All patients enrolled took aspirin and clopidogrel after stenting and received monthly clinical follow-up.Clinical outcomes included tlr and non-fatal myocardial infarction.It was reported that neointimal proliferation and neovascularization were more frequently observed in patients with dm than patients without dm.There was no significant difference in late lumen loss between the two groups.Uncovered struts,malapposition, and thrombus were also reported in both groups, at similar rates and the rates were noted to be quite low in both groups.It was stated that the intrastent microthrombus occurrence rate observed by oct was also similar between both groups and no clinical st (stent thrombosis) events were observed.It was also mentioned in relation to another study that a catch-up phenomenon had been reported which showed that the superiority of sirolimus-eluting stents compared with zotarolimus-eluting stents at 1-year follow-up with respect to occurrence of st was lost after 5 years.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• 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: 10886360
• MDR Text Key: 219376187
• Report Number: 9612164-2020-04564
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: P110013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2020
• 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
• Date Manufacturer Received: 10/28/2020
• 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 Outcome(s): Required Intervention
• Patient Weight: 70