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

Catalog Number	RONYX35026UX
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/04/2018
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
One resolute onyx drug-eluting stent was used to treat a lesion in the proximal left anterior descending (lad) artery with mild tortuosity and moderate calcification exhibiting 80% stenosis.There were no abnormalities reported in relation to patient's anatomy.There was no damage noted to the packaging.There were no issues noted when removing the device from the hoop/tray.The device was inspected with no issues.Negative prep was not performed.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.There was no resistance encountered when advancing the device and excessive force was not used during delivery.The device was not moved or re-positioned prior to the leak.It was reported that after the stent was passed through the lesion, an inflation at 12atm was attempted but only the proximal and distal ends of the stent inflated.This caused the stent to be partially deployed at either end and not in the middle of the stent.A second inflation at 18atm was attempted and the stent was fully deployed.It was noted that pressure was lost in the inflator indicating a leak.The procedure was completed with this stent.The patient is alive with no injury.
Additional Manufacturer Narrative
Evaluation summary: the balloon returned with blood visible in the balloon and inflation lumen.The balloon failed negative prep.A leak site could not be found during analysis.On pressurization of the device, the balloon and inflation lumen filled with blood.The inflation lumen became blocked with congealed blood and could not be dispersed in the waterbath despite multiple attempts.The distal shaft was cut distal to the congealed blood.The portion of the distal shaft was attached to a makeshift luer and an attempt was made to remove the congealed blood by performing negative prep.This failed due to a stretched balloon bond.The balloon was pressurized, and the balloon inflated successfully.The balloon could not be deflated due to balloon bond damage.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: 7661896
• Report Number: 9612164-2018-01607
• Device Sequence Number: 19490460
• Product Code: NIQ
• UDI-Device Identifier: 00643169557109
• UDI-Public: 00643169557109
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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
• Report Date (Section B): 10/19/2018

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: 10/09/2019
• Device Catalogue Number: RONYX35026UX
• Device Lot Number: 0008828242
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 06/05/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 07/04/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1