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

Catalog Number RONYX27512X

Device Problems Migration or Expulsion of Device (1395); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 03/01/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

During a procedure, an attempt was made to use a resolute onyx rx coronary drug eluting stent to treat a non tortuous, moderately calcified lesion exhibiting 50% stenosis in the proximal obtuse marginal (om).The device was inspected with no issues.Negative prep was not performed.The lesion was pre-dilated.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.Excessive force was not used during delivery.It was reported that following implantation of the resolute onyx stent at 14 atm, the position of the non-medtronic guide wire was lost.The physician stated that the felt the stent was fully opposed after expanding at 14 atm.After re-entering the wire into the vessel, the wire passed behind some struts of the stent, between the vessel wall and the stent.The wire tip became bent into a hook shape in the distal vessel.Balloon dilatations were then initiated using non-medtronic balloons at 16 atm to avoid malposition.As the wire was withdrawn from the vessel, it caught on the stent struts and completely pulled the stent out of the vessel.It was reported that the stent was retrieved back to the arm where it was snared and withdrawn through the sheath.It was reported that another onyx stent was used to successfully complete the procedure.No other patient injury reported.It is reported that this event was operator related and that the device was not at fault.

Manufacturer Narrative

It is also indicated that stent deformation occurred.If information is provided in the future, a supplemental report will be issued.

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: 8393553
• MDR Text Key: 137931155
• Report Number: 9612164-2019-00784
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2020
• Device Catalogue Number: RONYX27512X
• Device Lot Number: 0009399633
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2019
• Date Device Manufactured: 10/26/2018
• 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