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

Catalog Number RONYX20008X

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/22/2017

Event Type  malfunction  

Manufacturer Narrative

Product analysis image summary: the procedural images capture pre-dilation and successful deployment of two resolute onyx stent in the vessel.The 8mm resolute onyx stent is deployed in the diagonal overlapping the distal wraps of the proximally deployed stent.The stent appears to be moved distally on the guidewire as the post-dilation device is advanced.The migration indicates that the stent may not have been sufficiently apposed to the vessel wall.The stent is subsequently post-dilated in the more distal location.(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

The physician intended to use a resolute onyx drug eluting stent to treat a mildly tortuous, mildly calcified lesion with 90% stenosis in the ostium diagonal branch.The lesion was pre-dilated.There are no abnormalities reported in relation to anatomy.There was no damage noted to packaging.There were no issues noted when removing the device from the hoop.No difficulties were noted when removing the protective sheath.The device was inspected with no issues.The stent was inspected post removal of the protective sheath, no issues were noted.Negative prep was not performed.The device passed through a previously deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.It is reported that the stent migrated forward in the vessel to the distal part of the diagonal branch by 5mm.The device remains in the patient.No intervention was carried out.The health care professional could not justify stent removal by snare, by risk-benefit analysis.There is no patient injury.

• 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: 6896762
• MDR Text Key: 87879663
• Report Number: 9612164-2017-01325
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/24/2018
• Device Catalogue Number: RONYX20008X
• Device Lot Number: 0007908577
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2017
• Initial Date FDA Received: 09/27/2017
• Date Device Manufactured: 01/25/2016
• 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 Age: 81 YR
• Patient Weight: 65