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 Myocardial Infarction (1969); Thrombus (2101); Stenosis (2263); Injury (2348)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

Age: average age.Sex: majority gender.Date of event: date of publication journal article title: percutaneous treatment and outcomes of small coronary vessels literature reference: doi.Org/10.1016/j.Jcin.2019.10.062.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to compare the treatment outcomes of patients with de novo lesions in small coronary vessels undergoing percutaneous coronary intervention (pci) in sweden from april 2009 to july 2017 with drug-coated balloons (dcbs) or newer-generation drug-eluting stents (n-des).The in.Pact falcon was one brand of dcb used to treat patients in the dcb group within the study population.Patients included in the comparator n-des group were implanted with endeavor resolute, resolute integrity, and resolute onyx stents as well as the old-generation endeavor zotarolimus-eluting stent.A number of non-medtronic stents were also implanted in patients within this n-des group.14,788 patients with small-vessel cad were enrolled in the study: 1,154 were treated with dcbs and 13,634 with n-des.Altogether, 35,541 lesions were treated using 2,503 dcbs and 33,038 n-des.At a 3 year follow up, patients were assessed for the occurrence in the primary outcomes of restenosis and definite target lesion thrombosis and in secondary outcomes of all-cause death and myocardial infarction.Clinical outcomes reported in the study population included death, myocardial infarction, target lesion thrombosis, and restenosis.

• Brand Name: RESOLUTE INTEGRITY RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway ; IE
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 9984932
• MDR Text Key: 196912918
• Report Number: 9612164-2020-01633
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SW
• 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: 04/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• 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: 04/15/2020
• 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 Age: 69 YR