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

Device Problems Infusion or Flow Problem (2964); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2019

Event Type  malfunction  

Manufacturer Narrative

Journal article: "clinical impact of the gap-angle ratio in patients with ostial lesions of the right coronary artery undergoing percutaneous coronary intervention" journal: heart and vessels year: 2019 ref: https://doi.Org/10.1007/s00380-019-01417.There is no established or suspected causal relationship between the device and 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.Age: 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

Resolute onyx rx zotarolimus eluting stents were among a number of des stents implanted in the study population as part of a study investigating the incidence of binary restenosis and its predictors in patients with ostial lesions of the coronary artery (rcaos) who underwent percutaneous coronary intervention (pci).Lesions treated included the femoral, brachial, radial, funnel-shaped ostium and de novo.Clinical outcomes of the procedures include cardiac death, myocardial infarction (mi), target lesion revascularisation (tlr), stent edge dissection.Malfunctions included stent under expansion and stent protrusion.

Manufacturer Narrative

None of the death events or adverse events that were mentioned within the article related directly to medtronic devices/products.If information is provided in the future, a supplemental report will be issued.

• 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: 9451777
• MDR Text Key: 175702183
• Report Number: 9612164-2019-05112
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2019
• 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: 02/05/2020
• 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 Age: 72 YR