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

Catalog Number RONYX25038UX

Device Problem Torn Material (3024)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

One resolute onyx drug-eluting stent was opened to treat a lesion in the mid left anterior descending (lad) artery with moderate tortuosity and severe calcification.There was no damage noted to the packaging.There were issues noted on inspection and when removing the device from the hoop.The protective sheath was on the stent when the stent was removed from the hoop.No resistance was noted.Negative prep was not performed.The stent was handled directly by the physician after he removed the protective sheath himself.It was reported that a stent strut was deformed upon inspection post removal from the hoop.It was informed that the stent strut tore a hole in the physician's glove but did not break the skin.The device was not used in the patient.

Manufacturer Narrative

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: 7662213
• MDR Text Key: 113191542
• Report Number: 9612164-2018-01613
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556867
• UDI-Public: 00643169556867
• 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
• Report Date: 11/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2020
• Device Catalogue Number: RONYX25038UX
• Device Lot Number: 0008999166
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2018
• Date Device Manufactured: 02/16/2018
• 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