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

Model Number NCEUP4012X

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

Patient Problem Occlusion (1984)

Event Date 10/09/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure one resolute onyx des was used to treat the lad.26 months post index procedure during a revascularisation procedure one nc euhpora balloon catheter and one resolute onyx des were used and plaque shift occurred and was treated with implant of a resolute onyx des.

Manufacturer Narrative

Additional information: the investigator assessed the event was not related to index device or anti-platelet medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Correction: patient recovered.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: investigator assessed the event was unlikely related to index device or antiplatelets medication.Correction: event date (b)(6) 2019.If information is provided in the future, a supplemental report will be issued.

• Brand Name: NC EUPHORA RX
• Type of Device: CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS
• 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: 9503725
• MDR Text Key: 173966172
• Report Number: 9612164-2019-05280
• Device Sequence Number: 1
• Product Code: LOX
• UDI-Device Identifier: 00643169396227
• UDI-Public: 00643169396227
• 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,Followup,Followup,Followup
• Report Date: 02/21/2020

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 Expiration Date: 04/21/2019
• Device Model Number: NCEUP4012X
• Device Catalogue Number: NCEUP4012X
• Device Lot Number: 218014275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 01/21/2020; 11/23/2019; 02/19/2020
• Supplement Dates FDA Received: 01/28/2020; 02/19/2020; 02/21/2020
• Date Device Manufactured: 04/21/2017
• 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: 68 YR
• Patient Weight: 84