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

Model Number	RONYX27522W
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Reaction (2414)
Date of Event	07/20/2018
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
It was reported that a patient presented to hospital with a heart attack and had an index procedure on (b)(6) 2018 where one resolute onyx rx coronary drug eluting stent was implanted (2.75x22mm).Two additional resolute onyx rx coronary drug eluting stents were implanted two days later, during a staged procedure, because more disease was seen.The hospital did not fill out the stent id card.Patient states having issues since stent implantation.Patient states having swelling on inside and outside of mouth and down to chest and neck.States skin hurts and is tender and swollen.The symptoms were experienced while the patient was in the hospital but the patient was also on very high dose of prednisone for chron's disease and is still on this and suffers from an autoimmune disorder.Patient states being allergic to sulpha and nickel.Patient also states they are not taking their medication.Patient has been taken off two medications and the dosages reduced on two.The patient is due to see an allergist on (b)(6) 2018.Patient is feeling a little bit better and the symptoms come and go.Clinical assessment: possibility that symptoms could be due to patient not taking medication.

• Brand Name: RESOLUTE ONYX OTW
• Common Device Name: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• MDR Report Key: 7909897
• Report Number: 9612164-2018-02536
• Device Sequence Number: 2305284
• Product Code: NIQ
• UDI-Device Identifier: 00643169602434
• UDI-Public: 00643169602434
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Report Date (Section B): 09/26/2018

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: 04/08/2020
• Device Model Number: RONYX27522W
• Device Lot Number: 0009073233
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/11/2018
• Initial Report FDA Received Date: 09/26/2018
• 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: Other
• Patient Age: 66 YR
• Patient Weight: 56