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

Catalog Number RONYX20030UX

Device Problems Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 12/24/2018

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 a resolute onyx rx drug eluting stent to treat a lesion in the distal left main (lm) coronary artery.The lesion exhibited moderate tortuosity, severe calcification and 90% stenosis.The lesion was pre dilated.The device was inspected with no issues noted.The device passed through a previously deployed stent.Resistance was noted advancing the device to the lesion; however, excessive force was not used.It was reported that stent dislodgement occurred during removal following failed delivery.The stent was being delivered through a deployed stent in the lm and became caught in the struts.The device was removed with a snare and pulled into the guide catheter.No injury reported.

Manufacturer Narrative

Add info: the inflation device remained in neutral pressure during delivery of the device.The resolute onyx device became damaged when it caught on the struts of the previously deployed medtronic stent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis summary: the dislodged stent did return for analysis.Deformation was evident to the stent with struts stretched and overlapping.Hardened contrast was visible distal to the distal markerband.Crimp impressions were visible on the exposed balloon surface.The balloon folds were partially expanded.The inner lumen patency was verified with a 0.015 inch mandrel.No other damage evident to the remainder of the device.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: 8263613
• MDR Text Key: 133707077
• Report Number: 9612164-2019-00248
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556683
• UDI-Public: 00643169556683
• 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
• Report Date: 03/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2020
• Device Catalogue Number: RONYX20030UX
• Device Lot Number: 0009136882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/10/2018
• 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: 81 YR