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

Catalog Number	Z26EBU35
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Intimal Dissection (1333)
Date of Event	09/11/2018
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 index procedure one zuma catheter was used.It was reported that dissection occurred.The sponsor assessed the event as possibly related to the device and not related to the anti-platelet medication.
Additional Manufacturer Narrative
The patient has a medical history of hypertension, hyperlipidemia, diabetes.The index procedure was prompted by mi.The index procedure took place on the (b)(6) 2018 and the lad was treated.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: it was a resolute onyx device used during the index procedure.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 MA
• MDR Report Key: 8743773
• Report Number: 1220452-2019-00081
• Device Sequence Number: 19512211
• Product Code: NIQ
• UDI-Device Identifier: 00613994813060
• UDI-Public: 00613994813060
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K981198
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2019

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: 04/22/2020
• Device Catalogue Number: Z26EBU35
• Device Lot Number: 0009102540
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/31/2019
• Supplement Date Received by Manufacturer: 06/25/2019; 07/31/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 07/18/2019; 08/12/2019
• 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: Hospitalization
• Patient Age: 83 YR
• Patient Weight: 70