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

Model Number	RONYX22526UX
Health Effect - Clinical Codes	Pain (1994); No Consequences Or Impact To Patient (2199); Pericardial Effusion (3271)
Date of Event	07/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis summary: the stent was positioned on the balloon between the marker bands as per specifications.Deformation was evident to the 16th and 18th distal stent wraps with struts raised.No deformation was evident to the distal tip.The 0.015 mandrel would not load through the guidewire lumen due to hardened blood.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7684773
• Report Number: 9612164-2018-01720
• Device Sequence Number: 16779526
• Product Code: NIQ
• UDI-Device Identifier: 00643169556744
• UDI-Public: 00643169556744
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/18/2019
• Device Model Number: RONYX22526UX
• Device Catalogue Number: N/A
• Device Lot Number: 0008926939
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/20/2018; 08/08/2018; 09/12/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/14/2018; 10/03/2018; 10/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 77