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

Catalog Number EN35030JX

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

Patient Problems Death (1802); Pneumonia (2011); Sepsis (2067); Blood Loss (2597)

Event Date 07/24/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

During index procedure the physician used three endeavor (rx) drug eluting stents to treat a lesions located in the proximal and mid rca.Devices were successfully implanted and the patient was discharged two days later.Patient suffered a gi bleed approximately 58 months post index procedure.The patient was on aspirin and clopidogrel at the time of the event.Approximately 59 months post index it was reported that the patient expired.Cause of death listed as pneumonia and sepsis and not sudden or cardiac related.Investigator assessed that the event was not related to the study device treatment or therapy.

• Brand Name: ENDEAVOR 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: 5317567
• MDR Text Key: 34074631
• Report Number: 9612164-2015-01914
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 11/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: EN35030JX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/27/2015
• Initial Date FDA Received: 12/22/2015
• 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
• Treatment: CLOPIDOGREL AND ASPIRIN.
• Patient Outcome(s): Hospitalization
• Patient Age: 00076 YR