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

Catalog Number RONYX22515UX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 05/16/2019

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

During index procedure, four resolute onyx drug-eluting stents were implanted in the lad, r-pda and rca.Approximately 21 months post procedure, patient suffered acute blood loss anemia secondary to prepyloric ulcer.Event was treated with blood transfusion and medication.Patient was on dapt within 24 hours prior to event.Sponsor assessed event as not related to device but possibly related anti platelet medication.

Manufacturer Narrative

Additional information: during index procedure three resolute onyx drug-eluting stents were implanted in the lad, r-pda and rca.The fourth resolute onyx dr ug-eluting stent was implanted during a revascularization procedure 13 months post index procedure.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: patient recovered.Investigator assessed that the event was unlikely related to device and antiplatelets medication.If information is provided in the future, a supplemental report will be issued.

• Brand Name: RESOLUTE ONYX RX
• Type of Device: STENT, CORONARY, DRUG-ELUTING
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 9144289
• MDR Text Key: 160841506
• Report Number: 9612164-2019-04177
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556713
• UDI-Public: 00643169556713
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2019
• Device Catalogue Number: RONYX22515UX
• Device Lot Number: 0008547667
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2019
• Date Device Manufactured: 03/23/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 75 YR
• Patient Weight: 112