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

Model Number	RONYX35038UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	07/16/2019
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 rx coronary drug eluting stent and a telescope guide extension catheter were used to treat a severely calcified and tortuous friable lesion in the mid proximal right coronary artery (rca).The devices were inspected with no issues noted.The telescope device was prepped as per ifu, onyx negative prep was performed with no issues.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.It was reported that while both devices were advancing a contained dissection was encountered.No additional patient injury.
Additional Manufacturer Narrative
It was reported that the dissection was due to calcification and the nature of the vessel.It was detailed that dissections occur also with non medtronic guide liner's.The dissection was contained and was treated with a stent.The resolute onyx device was removed and replaced with a non medtronic stent.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: 8797493
• Report Number: 9612164-2019-02898
• Device Sequence Number: 2838335
• Product Code: NIQ
• UDI-Device Identifier: 00643169557130
• UDI-Public: 00643169557130
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 09/25/2019

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: 05/19/2021
• Device Model Number: RONYX35038UX
• Device Catalogue Number: RONYX35038UX
• Device Lot Number: 0009747920
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/18/2019; 09/24/2019
• Initial Report FDA Received Date: 07/17/2019
• Supplement Report FDA Received Date: 08/12/2019; 09/25/2019
• 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: 71 YR