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

Catalog Number RONYX22512UX

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/16/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

An attempt was made to use one resolute onyx rx coronary drug eluting stent to treat a severely tortuous, mildly calcified lesion exhibiting 90% stenosis located in the distal obtuse marginal (om).The device was inspected with no issues.The lesion was pre-dilated.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.Excessive force was used during delivery.It was reported that stent dislodgement occurred during removal following a failed delivery.The dislodged stent was not removed from the patient; it was pressed into the vessel wall by deploying another stent.The dislodged stent remains trapped behind the other stent.It is indicated that the om received multiple stents as well as the lad, in addition to the stent in the left main.The patient is reported to be alive.

Manufacturer Narrative

Image analysis summary: the images capture lesion sites visible in the lcx and obtuse marginal.The first set of images provided captures the successful treatment of the lad with unidentified stent and balloon devices.The successful deployment of stents in the lcx and lm are visible from the images.The next images capture the dislodged stent in the lm, immediately distal to the guide catheter.There were no images capturing the attempted delivery of the resolute onyx 2.25x12mm device, or the subsequent removal of the delivery system.A stent is then deployed at the site of the dislodged stent with success, and the crushed dislodged stent is visible within the deployed stent in the next images.The images then further capture the treatment of the lcx vessel with unidentified devices.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: 8114983
• MDR Text Key: 128736919
• Report Number: 9612164-2018-03417
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556706
• UDI-Public: 00643169556706
• 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: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2020
• Device Catalogue Number: RONYX22512UX
• Device Lot Number: 0009021968
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• Date Device Manufactured: 03/05/2018
• 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): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 44