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

Catalog Number	RONYX27508UX
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	03/30/2019
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
During an index procedure two resolute onyx coronary des were implanted in the lad.Approx ten days later the patient suffered upper gi bleed reported as most likely secondary to known hiatal hernia and cameron erosions in the setting of dual antiplatelet therapy.Patient was on dapt at the time of the event.The patient was treated with medication.Investigator assessed the event as not related to the index device and possibly related to the antiplatelet medication.Patient recovered.(updates 02/05 -apr-19 reviewed).
Additional Manufacturer Narrative
Cec adjudicated the bleeding event as barc type 3a and commented less that 5mg drop plus blood transfusion.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: cec adjudicated the bleeding event as barc type 2 with no blood transfusion.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: 8564386
• Report Number: 9612164-2019-01495
• Device Sequence Number: 11310905
• Product Code: NIQ
• UDI-Device Identifier: 00643169556874
• UDI-Public: 00643169556874
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/26/2019

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: 11/13/2019
• Device Catalogue Number: RONYX27508UX
• Device Lot Number: 0008877850
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 06/06/2019; 09/11/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 07/02/2019; 09/26/2019
• 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: Other
• Patient Age: 79 YR
• Patient Weight: 79