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

Model Number	RONYX27534UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Thrombus (2101)
Date of Event	08/01/2018
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 procedure, an attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a moderately tortuous and mildly calcified lesion located in the mid to distal cx artery.There were no abnormalities in relation to the anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.The device was inspected with no issues noted.Negative prep was not performed.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It was reported that the device was advanced over the wire for primary stenting and inflated at 14 atm's.An angiogram was performed and a perforation at the distal end of the stent and vessel was observed.A euphora balloon was advanced into the proximal portion of the stent and inflated at 14atm.The balloon was removed.Protamine was given, however extravasation was still noted.A non-medtronic balloon was inserted into resolute onyx stent and inflated for ten minutes.Extravasation was still noted.A non-medtronic stent was inserted into the distal end of the resolute onyx and vessel and a small leak was still noted.An euphora balloon was inserted and several inflation¿s performed at 7atms.The balloon was removed and an angiogram performed.The vessel closed off due to in stent thrombus and sealed off the perforation.Patient status post-procedure is alive.
Additional Manufacturer Narrative
The stent was fully expanded.The thrombus was noted after protamine was given at end of the procedure.Anticoagulant and dapt was given during procedure.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: 7796465
• Report Number: 9612164-2018-02092
• Device Sequence Number: 19199678
• Product Code: NIQ
• UDI-Device Identifier: 00643169556942
• UDI-Public: 00643169556942
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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,Followup
• Report Date (Section B): 01/17/2019

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: 11/23/2019
• Device Model Number: RONYX27534UX
• Device Lot Number: 0008890311
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/01/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 01/16/2019
• Initial Report FDA Received Date: 08/20/2018
• Supplement Report FDA Received Date: 09/18/2018; 01/17/2019
• 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