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

Model Number RONYX22522UX

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993); Physical Resistance/Sticking (4012)

Patient Problems Cardiopulmonary Arrest (1765); Death (1802); Pain (1994); Pericardial Effusion (3271)

Event Date 07/07/2018

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that an attempt was made to use a resolute onyx drug eluting stent to treat a lesion in the mid lad with mild tortuosity and calcification and 100% stenosis.No abnormalities were noted in the patient¿s anatomy.The device was removed from packaging with no issues noted.The device was inspected with no issues noted.Negative prep was performed with no issues noted.The lesion was predilated.Resistance was encountered, and excessive force was not used.It was reported that stent deformation occurred during positioning and advancement in the artery.When the device was removed from the patient, it was noted that a stent strut was lifted.The lesion was re-predilated using a non-medtronic balloon and two other resolute onyx stents were implanted with no issues noted.Post procedure, the patient complained of pain and an echo was performed.Fluid was found in the patient's heart.Pericardiocentesis was performed and 35cc of fluid removed.The patient coded and passed away on the helicopter pad awaiting transfer.No further patient complications reported for this event.

Manufacturer Narrative

Additional information received reported that there was no evidence of a stent thrombosis.It is believed that the patient death is unrelated to the stents, as the patient coded prior to coming to the lab and then coded again after the procedure.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

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: 7684783
• MDR Text Key: 113873126
• Report Number: 9612164-2018-01721
• 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,Followup,Followup
• Report Date: 12/19/2018

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: 09/02/2019
• Device Model Number: RONYX22522UX
• Device Catalogue Number: RONYX22522UX
• Device Lot Number: 0008780149
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2018
• Initial Date FDA Received: 07/13/2018
• Supplement Dates Manufacturer Received: 07/17/2018; 08/08/2018; 12/04/2018
• Supplement Dates FDA Received: 08/14/2018; 10/03/2018; 12/19/2018
• Date Device Manufactured: 09/02/2017
• 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
• Patient Age: 78 YR
• Patient Weight: 77