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

Model Number RONYX22530UX

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 01/13/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

One 2.25x34mm resolute onyx drug eluting stent was successfully implanted in the mid lad ((b)(6) 2020) at different facility.Approx 3 days later ((b)(6) 2020) the patient presented with stemi, and the lad was 100% totally occluded from the distal lm.There was no flow in lad and circumflex and ramus vessels.The patient was taking dapt as prescribed.An attempt was made to treat the patient with two resolute onyx rx coronary drug-eluting stents (2.25x30mm resolute onyx, and 3.5 x 22mm resolute onyx).The lesion was a moderately tortuous, moderately calcified lesion located in the mid, proximal left main (lm) coronary artery/left anterior descending (lad) artery/ramus branch.Both devices were inspected with no issues noted.Negative prep was performed on both devices without issues.Both devices did not pass through previously deployed stents.The lad and circumflex vessels were wired and pre-dilated.Resistance was not encountered when advancing the 3.5 x 22mm resolute onyx device.Excessive force was not used during delivery.Resistance was encountered when advancing the 2.25x30mm resolute onyx.A resolute onyx stent was placed in the proximal circumflex.The 3.5 x 22mm resolute onyx stent was placed in the distal lm to mid lad overlapping the 2.25 x 34mm resolute onyx stent that was previously implanted 3 days earlier.There was no issue during deployment of the 3.5 x 22mm resolute onyx stent and it was fully expanded.The ramus was wired and the 2.25x30mm resolute onyx (pli 10) was advanced through to the ramus branch.It was reported that the 2.25x30mm resolute onyx stent failed to cross the lesion and upon attempting to remove the undeployed stent, significant resistance was felt.It was noted on removal of the balloon that the 2.25x30mm resolute onyx stent had dislodged in the proximal lad.The 2.25x30mm resolute onyx stent was successfully retrieved using a goose neck snare.However, upon pulling back the 2.25x30mm resolute onyx stent with the snare, it got caught and pulled out the 3.5 x 22mm resolute onyx stent that had just been deployed in the lad, with both stents coming back into the guide.Another 3.5 x 22 onyx was implanted successfully in the proximal lad.Patient is currently in the icu without a balloon pump.

Manufacturer Narrative

Additional information: the stent implanted in the mid lad at the first hospital was a resolute onyx 2.5 x 34mm and it was deployed at 17 atm for 20 secs.The lesion had been pre-dilated with 1.5mm, 2.0mm and 2.5mm euphora balloon catheters.Three days later at the second hospital, an export aspiration catheter was used.2.0mm, 2.5mm and 3.0mm sc euphora balloon catheters were used.A 2.5x15mm resolute onyx drug eluting stent was deployed at 16 atm in the lcx.The 3.5 x 22mm resolute onyx stent was fully expanded at 18atm.Product analysis summary: the stent was not present on the balloon.Crimp impressions were visible on the exposed balloon surface.The balloon folds remained intact.The inner lumen could not be verified with a 0.015 inch mandrel most likely due to hardened blood in the guidewire lumen.Kinks were evident to both the transition shaft and the distal shaft.Two stents from returned entangled together.Extensive deformation was visible to both stents with struts stretched and bunched, as a result it was not possible to determine a difference between the stents.Image analysis summary: a photograph was provided of what looks like two dislodged stents.Both stents are severely deformed and entangled together.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Image analysis summary: angiographic and ivus images were received for review.Intravascular ultrasound images of the left main, left coronary artery and ramus branch were reviewed.From the images provided the moderate calcified anatomy of the vessel can be confirmed.Severe luminal narrowing with the intimal ¿ medial wall thickening with circular plaque of predominantly fibrous-lipid tissue was observed.Post deployment of the stent, the underexpansion and non-uniform position of the stent struts was observed and reported dislodgement of the stent was probable but cannot be confirmed with the provided images.It was reported that two stents tangled together during the stent retrieval, but the images provided cannot confirm this information.An angiographic image confirms the total occlusion as reported from the account.The vessel is confirmed as moderately tortuous with a moderately calcified lesion located in the mid, proximal left main (lm) coronary artery/left anterior descending (lad) artery/ramus branch.There is no contrast flow through the lad, lcx and ramus vessels.The 3.5 x 22mm stent is delivered and deployed in the left main and proximal lad.The ramus vessel is wired, and a predilatation balloon is delivered and inflated in the proximal vessel.The wire in the ramus appears to be delivered through a cell of the newly deployed stent in the left main (lm).Coronary angiography (cag) with contrast showing the left coronary vasculature prior to attempts to deliver the stent to the ramus.There is a 32-minute time elapse from this image to the next image suggesting that the attempted delivery and subsequent dislodgement of the 2.25 x 30mm resolute onyx stent.The mechanism of delivery difficulties, the dislodgement, catching of the dislodged stent and removal of the newly deployed lm stent do not appear to have been captured on the fluoroscopic images.But it appears most likely that the delivery of the stent through the cell of the lm stent into the ramus resulted in delivery difficulties.And then during snare removal of the dislodged stent the removal of the lm stent also occurred.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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
• MDR Report Key: 9646384
• MDR Text Key: 182398664
• Report Number: 9612164-2020-00481
• Device Sequence Number: 1
• Product Code: NIQ
• UDI-Device Identifier: 00643169556751
• UDI-Public: 00643169556751
• Combination Product (y/n): N
• PMA/PMN Number: P160043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/15/2021
• Device Model Number: RONYX22530UX
• Device Catalogue Number: RONYX22530UX
• Device Lot Number: 0009873532
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2020
• Date Manufacturer Received: 04/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 81 YR