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

Catalog Number	RONYX27530UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Myocardial Infarction (1969); Thrombus (2101); Stenosis (2263)
Date of Event	03/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During the initial procedure, two resolute onyx drug eluting stents to treat a lesion in the proximal right coronary artery, exhibiting 95% stenosis.The lesion was identified as diffuse and mildly calcified.The lesion showed mild angulation and mild tortuosity.There was no damage noted to packaging.There were no issues noted when removing the devices from the hoop/tray.The devices were inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The devices did not pass through a previously-deployed stent.Resistance was not encountered when advancing the devices.Excessive force was not used during delivery.The 2.75 x 30mm stent was deployed at 12 atms, inflated once, and the 3.0 x 12mm stent was inflated once and deployed at 15 atms.Approx 8 days post procedure the patient presented with a stemi.Lesion is being treated for in stent restenosis, thrombus present.The lesion was treated with a non-medtronic stent and balloons.The patient is reported as being alive without injury.
Additional Manufacturer Narrative
Cine image review: the images capture a stenotic lesion site visible within the previously deployed resolute onyx stents in the rca.Thrombus is present as reported by the account.The lesion is treated with a non-medtronic balloon device with good results, and blood flow is restored to the rca vessel.The remaining images capture the treatment of the vessel with a non-medtronic stent.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: 7555902
• Report Number: 9612164-2018-01282
• Device Sequence Number: 11227891
• Product Code: NIQ
• UDI-Device Identifier: 00643169556935
• UDI-Public: 00643169556935
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P160043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/11/2019
• Device Catalogue Number: RONYX27530UX
• Device Lot Number: 0008627186
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 08/15/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 09/11/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR