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

Catalog Number RONYX25038X

Device Problems Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/19/2018

Event Type  malfunction  

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 lesion.The device was inspected with no issues.Negative prep was not performed.The device passed through a previously deployed stent.Resistance was encountered when advancing the device.It was reported that the stent failed to cross through a previously deployed stent and became detached.The detached stent remains inside the previously deployed stent.The patient is reported to be alive with no injury.

Manufacturer Narrative

The target lesion was a severely tortuous and severely calcified lesion in the mid rca.Stenosis was 90%.The entire rca was pre-dilated.A 3.0x19mm non-medtronic stent was deployed prior to introducing the resolute onyx.It was reported that there was a dissection at the distal end of the non-medtronic stent.The non-medtronic stent was not post dilated to treat the dissection prior to the introduction of the resolute onyx.No resistance was encountered when advancing the resolute onyx through the previously deployed stent.However, when positioning and moving backwards, before inflation could be performed distally, close to the dissection, large resistance was encountered.The resolute onyx did not dislodge and was not deployed.The resolute onyx was removed from the patient just by pulling without the need for additional equipment.It was reported that two stents were hooked together, and the previously deployed non-medtronic stent was explanted from the patient with the resolute onyx.Another non-medtronic stent was then successfully implanted.It was previously reported that there was a detachment, but it has been confirmed that there was no break and no separation.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: 8099690
• MDR Text Key: 128204002
• Report Number: 9612164-2018-03329
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup
• Report Date: 12/14/2018

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: 08/26/2020
• Device Catalogue Number: RONYX25038X
• Device Lot Number: 0009295339
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/19/2018
• Initial Date FDA Received: 11/23/2018
• Supplement Dates Manufacturer Received: 11/29/2018
• Supplement Dates FDA Received: 12/14/2018
• Date Device Manufactured: 08/27/2018
• 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 Age: 60 YR
• Patient Weight: 70