MAUDE Adverse Event Report: MEDTRONIC IRELAND LTD ENDEAVOR RX; STENT, CORONARY, DRUG-ELUTING

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

Patient Problems Myocardial Infarction (1969); Stenosis (2263)

Event Date 10/17/2017

Event Type  Injury  

Manufacturer Narrative

Title: comparison of mid-term clinical outcomes after treatment of ostial right coronary artery lesions with early and new generation drug-eluting stents: insights from an international multicenter registry authors: satoru mitomo, richard jabbour, yusuke watanabe, antonio mangieri, marco anconaantonio colombo journal: international journal of cardiology year: 2018 issue #: 254 literature reference: https://doi.Org/10.1016/j.Ijcard.2017.10.If information is provided in the future, a supplemental report will be issued.

Event Description

Endeavor and resolute integrity des devices were among devices, including non-medtronic devices, that were used in the treatment of right coronary artery (rca) aorto-ostial (ao) lesions with early and new generation drug-eluting stents included in a study to compare mid-term clinical outcomes after treatment of ostial right coronary artery lesions with early and new generation drug-eluting stents.Death, mi ,target lesion failure (tlr/tvr) and stent malposition events were reported to have occurred within the study population.

• Brand Name: ENDEAVOR RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND LTD; parkmore business park; ballybrit; galway
• Manufacturer (Section G): MEDTRONIC IRELAND LTD; parkmore business park; ballybrit; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8183814
• MDR Text Key: 130980277
• Report Number: 9612164-2018-03736
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: P060033
• 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: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• 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: 09/21/2018
• 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): Other
• Patient Age: 69 YR