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

Model Number RONYX27534X

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Appropriate Term/Code Not Available (3191)

Patient Problems Death (1802); Myocardial Infarction (1969); Renal Failure (2041); Cardiogenic Shock (2262)

Event Date 07/06/2018

Event Type  Death  

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 implanted in the lad.Approximately four days post procedure, patient suffered a cardiogenic shock secondary to nstemi in the rca.Patient received blood transfusion and was intubated.Investigator assessed that the event was not related to antiplatelets medication, but possibly related to index device.Patient died.

Manufacturer Narrative

Lot number of index device received.Patient was admitted for acute pulmonary oedema secondary to end stage renal failure with the nstemi.Death was classified as non sudden cardiac death.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

Manufacturer Narrative

Cec assessed the event as death - cardiac death.Likely heart failure in setting esrd.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec assessed the mi and stent thrombosis as no event.Cec commented that there was no clinical evidence of mi.No enzymes just cardiogenic shock.The patient suffered cardiac failure and died.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: 7725448
• MDR Text Key: 115185660
• Report Number: 9612164-2018-01872
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: P160043
• 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,Followup,Followup,Followup,Followup
• Report Date: 01/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2020
• Device Model Number: RONYX27534X
• Device Catalogue Number: RONYX27534X
• Device Lot Number: 0009006631
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2019
• Date Device Manufactured: 02/25/2018
• 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; Other; Required Intervention
• Patient Age: 48 YR
• Patient Weight: 54