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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stroke/CVA (1770); Myocardial Infarction (1969); Thrombus (2101); Injury (2348); Blood Loss (2597)

Event Date 04/10/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Journal article:effectiveness and safety of zotarolimus-eluting stent (resolute¿ integrity) in patients with diffuse long coronary artery disease.Title: journal: korean circulation journal year: 2019 ref: https://doi.Org/10.4070/kcj.2019.0018.Date of publication additional information: dapt - clopidogrel and aspirin.Prasugrel or ticagrelor.There is no information to suggest the device caused or contributed to the death events.Deaths are common occurrences in clinical studies, however the cause(s) of death are often not characterized or clearly associated with a particular product.Therefore, deaths will not be considered reportable unless clearly stated as being associated with a medtronic device.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported in a journal article that a selection of patients in a study received resolute integrity rx (r-zes) and endeavour resolute drug eluting stents and non medtronic stents.The purpose of this study was to determine the effectiveness and safety of resolute integrity rx in patients with dlcad, a particularly long lesion =25 mm.Antiplatelets medication were administered to all patients prior to the index procedure.Adverse events experienced included bleeding complication, cva, stent thrombosis, cardiac death, non-fatal mi, mace (defined as the composite of cardiac death, non-fatal myocardial infarction (mi), definite stent thrombosis (st), and clinically-driven target vessel revascularization (tvr) at 12-month follow-up), target lesion revascularization, target and nontarget vessel revascularization.The incidence of tvr and mace were relatively low and that of definite st was rare at 12-month follow up.Therefore, the study demonstrated that r-zes had an excellent 1-year clinical outcome in study patients with dlcad.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8797779
• MDR Text Key: 151281893
• Report Number: 9612164-2019-02907
• 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: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2019
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR