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

Model Number RONYX35018UX

Device Problems Deflation Problem (1149); Inflation Problem (1310); Migration or Expulsion of Device (1395); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/05/2018

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 coronary drug eluting stent to treat a lesion.The device was inspected with no issues.Negative prep was performed with no issues.It was reported that the balloon of the device would not deflate at the lesion site, therefore a subsequent balloon was required to fully deploy the stent.The patient is reported to be alive with no injury.

Manufacturer Narrative

Relevant history: history of cad and stemi.Presented with moderate to severe lad disease, and pain during exertion and even at rest due to ischemia additional information: the proximal and mid lad was calcified.The lesion was pre-dilated with a 2.75 x 8mm non-medtronic balloon at 10atm.The 3.5 x 18mm resolute onyx inflated only at the edges initially.The stent was partially deployed.Multiple unsuccessful attempts were made to inflate the balloon.It was difficult to remove the stent delivery balloon from the partially deployed stent.It was reported that the stent moved backwards.A 2.5 x 12mm non-medtronic balloon was used to post dilate the stent at 15atm.A very good result was achieved.Then, a 3.5 x 12mm non-medtronic balloon was used to post dilate the stent at 12atm.An excellent result was achieved.Then another 3.5 x 8mm resolute onyx was deployed directly after the 3.5 x 18mm resolute onyx at 12 atm.Both stents were then post-dilated at 12atm.An excellent result was achieved with no complications.Product analysis summary: the balloon was deflated on return.Crystallized contrast was visible in the balloon and inflation lumen.There was no stretching evident to proximal balloon bond.The delivery system was placed in the water bath to disperse the crystallized contrast in order to aid inflation.The delivery system was inflated to nominal pressure of 12atm with no issues noted.The balloon deflated from rbp of 18atm in 11 seconds with no issues noted.No damage was evident to the remainder of the delivery system.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional info: no difficulties removing the protective sheath or stylet of the device.An attempt was made to use one resolute onyx rx drug eluting stent to treat a long stenosed lesion in the proximal lad exhibiting 70-80% stenosis.During delivery, no resistance was encountered.The device was not moved or re-positioned at the lesion.It was reported that the stent balloon would not inflate in the center.It was reported that the balloon of the device would not deflate at the lesion site following the first inflation.The balloon deflated slowly.50/50 contrast / saline was used.The patient is reported to be alive with no injury.The physician kept pulling negative prep until the balloon free of stent.A subsequent balloon was required to fully deploy the stent.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: 8169654
• MDR Text Key: 130520894
• Report Number: 9612164-2018-03649
• Device Sequence Number: 1
• Product Code: NIQ
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2019
• Device Model Number: RONYX35018UX
• Device Catalogue Number: RONYX35018UX
• Device Lot Number: 0008618053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/06/2017
• 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: 65 YR
• Patient Weight: 72