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

Catalog Number RONYX25034UX

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Myocardial Infarction (1969); Occlusion (1984)

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

Manufacturer Narrative

Image analysis summary: images were provided 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.Correction: device catalog number.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: 9646405
• MDR Text Key: 177380327
• Report Number: 9612164-2020-00484
• 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: Physician
• 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?: No
• Device Operator: Health Professional
• Device Catalogue Number: RONYX25034UX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/22/2020
• 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): Hospitalization; Required Intervention
• Patient Age: 81 YR