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

Catalog Number	RONYX30008UX
Medical Device Problem Codes	Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	01/04/2018
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
A resolute onyx drug eluting stent was attempted to be used during a procedure to treat a lesion in the ostium of the lad/cx.Tortuosity was mild.Calcification was mild.No damage was noted to packaging and no issues noted when removing the device from the hoop/tray.The device was inspected and negative prep was performed with no issues.The lesion was not pre-dilated.Resistance was encountered when advancing the device.Excessive force was not used during delivery.It was reported that stent dislodgement occurred during delivery.The dislodged stent was removed by snare.Abnormalities were reported in relation to anatomy; the stent was believed to have caught on an ostial lad stent.The device was replaced by another medtronic product.Patient status post procedure is alive ¿ no injury.
Additional Manufacturer Narrative
Additional information: lesion exhibited 90% stenosis.Product analysis: the stent was returned for analysis.The delivery system did not return for analysis.Stent was returned attached to snare.Deformation was evident to the entire stent wraps, with struts raised, bunched and overlapping.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.

• 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: 7224142
• Report Number: 9612164-2018-00157
• Device Sequence Number: 19203756
• Product Code: NIQ
• UDI-Device Identifier: 00643169556966
• UDI-Public: 00643169556966
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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
• Report Date (Section B): 05/28/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/25/2019
• Device Catalogue Number: RONYX30008UX
• Device Lot Number: 0008768986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2018
• Initial Date Received by Manufacturer: 01/10/2018
• Supplement Date Received by Manufacturer: 02/08/2018; 05/11/2018
• Initial Report FDA Received Date: 01/29/2018
• Supplement Report FDA Received Date: 03/07/2018; 05/28/2018
• 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: 85 YR