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

Catalog Number	RONYX22538UX
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/16/2018
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 is reported that a resolute onyx drug eluting stent device became damaged (stent strut was bent) in a calcified circumflex artery; positioning difficulties were experienced.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information: the device was inspected before use with no issues noted.The lesion was pre-dilated.Resistance was noted while advancing the device to the lesion.Excessive force used.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: the returned procedural images capture the treatment of a calcified and tortuous rca.The reported treated lesion was the circumflex artery.The study date on the images do not match the reported event date.It appears likely that the images provided are not related to the complaint procedure.The returned images capture a previously implanted stent in the proximal rca.A stent is delivered through the previously implanted stent and implanted in the target lesion.Post dilation is then performed with improved flow visible post implantation.The reported positioning difficulties and damaged stent were not captured in the images provided.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: 7266098
• Report Number: 9612164-2018-00346
• Device Sequence Number: 1890296
• Product Code: NIQ
• UDI-Device Identifier: 00643169556775
• UDI-Public: 00643169556775
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2018

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: 09/19/2019
• Device Catalogue Number: RONYX22538UX
• Device Lot Number: 0008802318
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2018
• Supplement Date Received by Manufacturer: 03/14/2018; 09/24/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 04/10/2018; 10/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR