MAUDE Adverse Event Report: MEDTRONIC MEXICO NC EUPHORA RX; CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS

Model Number NCEUP27506X

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

Patient Problem Death (1802)

Event Date 05/20/2020

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During the index procedure three resolute onyx des were implanted in the 2nd obtuse marginal.Two days later during a staged procedure, three resolute onyx des were implanted; two in the ramus and one in the lcma.One nc euphora balloon catheter was also used staged procedure.Approximately 20 months later the patient suffered cardiogenic shock, severe mitral regurgitation, worsening renal failure and died.Death was classified as non sudden cardiac death.Investigator and sponsor assessed the event as not related to index device or anti-platelet medication.Safety commented "death." cec adjudicated the death as a cardiac death.

• Brand Name: NC EUPHORA RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; IE ; 091708734
• MDR Report Key: 10783697
• MDR Text Key: 214505756
• Report Number: 9612164-2020-04228
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169396128
• UDI-Public: 00643169396128
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141090
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2020
• Device Model Number: NCEUP27506X
• Device Catalogue Number: NCEUP27506X
• Device Lot Number: 215537429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/16/2020
• Date Device Manufactured: 05/25/2018
• 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): Death; Hospitalization; Life Threatening; Other; Disability
• Patient Age: 77 YR
• Patient Weight: 104