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

Catalog Number RONYX25026UX

Device Problems Fracture (1260); Material Deformation (2976)

Patient Problems Occlusion (1984); Thrombus (2101); Patient Problem/Medical Problem (2688)

Event Date 12/12/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

There were no abnormalities in relation to anatomy.The target lesion was in the proximal ramus, exhibiting 95% stenosis.A 2.5x26mm resolute onyx drug eluting stent was intended to be used to treat the target lesion.There was no damage noted to packaging.There were no issues noted when removing the devices from the hoop/tray.The device was inspected with no issues identified.Negative prep was performed with no issues noted.The lesion was pre-dilated.The device did not pass through a previously-deployed stent.Resistance was not encountered when advancing the device.Excessive force was not used during delivery.The lesion was tubular.The lesion showed irregular contour.During the procedure, the resolute onyx stent was deployed at 14 atm in the target lesion.The patient developed cp and st elevation in early recovery.Angiography showed a 100% occluded stent.It was reported that stent thrombosis occurred.Inflations were performed with 2.0 and 2.5mm non-medtronic balloons.Timi 3 flow was restored.A persistent defect was noted in prox 1/3 of the stent.Ivus was performed.The prox third of the stent was noted to have a segment with dropout of a stent strut, possibly a stent fracture or a defect in coverage from scaffolding.A 2.5x23mm non-medtronic stent was deployed with excellent result.Repeat ivus showed excellent coverage and scaffolding along entire treated segment.The patient is reported as being alive without injury.Plavix was administered during the procedure.Asa and plavix recommended for min of 1 year.

Manufacturer Narrative

Cine image review: the images capture a lesion site in the ramus exhibiting 95% stenosis.Calcification is evident in the vessel from the images.The previously deployed resolute onyx stent was visible in the vessel.There was no evidence of stent fracture from the images, however the images appear to depict the separation of the previously adjacent not welded stent wraps that may have deformed/separated in the severely calcified lesion.The images captured treatment of the vessel with numerous balloon and stent devices.The final image shows the deployed stents within the ramus vessel after treatment, with good results.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: 7556150
• MDR Text Key: 109616728
• Report Number: 9612164-2018-01292
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556836
• UDI-Public: 00643169556836
• 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: 09/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/24/2019
• Device Catalogue Number: RONYX25026UX
• Device Lot Number: 0008849406
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2018
• Date Device Manufactured: 10/24/2017
• 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): Required Intervention
• Patient Age: 64 YR