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

Catalog Number RONYX30012UX

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

Patient Problem Septic Shock (2068)

Event Date 02/27/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

The event was prompted by unstable angina.During the index procedure, two resolute onyx des were implanted in the proximal lad and 1st obtuse marginal.Approximately 6 months post index procedure the patient suffered a septic shock and died.The patient received iv fluid resuscitation, 2u prbc and iv bicarbonate.It was informed that 2 days prior to the event, the patient had a pneumonia with acute respiratory distress.The investigator assessed that the event was not related to device or anti-platelets medication.The patient died on the same day of the event.

Manufacturer Narrative

Cec assessed the event as non cardiovascular death and stent thrombosis as no event.The patient also had a medical history of anemia, gastric bypass, bladder cancer, pe and diabetes.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX 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: 7380588
• MDR Text Key: 103771614
• Report Number: 9612164-2018-00593
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• 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
• Report Date: 01/03/2019

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: 01/17/2019
• Device Catalogue Number: RONYX30012UX
• Device Lot Number: 0008453546
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/27/2018
• Initial Date FDA Received: 03/29/2018
• Supplement Dates Manufacturer Received: 12/05/2018
• Supplement Dates FDA Received: 01/03/2019
• Date Device Manufactured: 01/17/2017
• 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): Death; Other
• Patient Age: 72 YR
• Patient Weight: 75