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

Model Number RONYX22518UX

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

Patient Problems Anemia (1706); Blood Loss (2597)

Event Date 12/23/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During the index procedure, one resolute onyx stent was implanted into the rca.Approx 4 days post index procedure, the patient suffered rectal bleeding.The patient was on dapt at the time of the event.The investigator assessed the event as not related to the index device but possibly related to anti-platelet medication.The event is unresolved.

Manufacturer Narrative

Patient presented with anemia and was treated with blood transfusion and a colonoscopy.Patient recovered from rectal bleeding.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

The patient was also treated with medication.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Cec adjudicated the bleeding event as barc type 3a.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: event date updated.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: event date updated.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: 8269902
• MDR Text Key: 133828193
• Report Number: 9612164-2019-00272
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556720
• UDI-Public: 00643169556720
• 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,Followup,Followup
• Report Date: 01/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/22/2020
• Device Model Number: RONYX22518UX
• Device Catalogue Number: RONYX22518UX
• Device Lot Number: 0009293436
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/10/2019
• Date Device Manufactured: 08/23/2018
• 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): Hospitalization; Other; Required Intervention
• Patient Age: 63 YR
• Patient Weight: 97