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

Catalog Number RONYX30026JX

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906)

Patient Problems Occlusion (1984); Thrombus (2101)

Event Date 01/15/2019

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 one resolute onyx rx coronary drug eluting stent to treat a bifurcation lesion located in the lad with 75% stenosis.The lesion was pre dilated and post dilated.It was reported that after stent implantation at 15 atm for 10 seconds, kissing balloon technique was performed with the left anterior descending artery (main) and 1st diagonal (d1).After that, there was a slight gap between proximal region of stent and the blood vessel wall, so post-dilation was performed with a non-compliant balloon catheter.It was indicated that there was no problem if there was a slight gap, and the procedure was completed.Approx 5 hours after the procedure the patient complained of considerable strong chest pain, and the patient entered the catheter room on suspicion of atrial tachycardia (at).When the angiography was performed with the diagnosis catheter, a total occlusion from stented proximal region to distal region was seen.The patients medication was changed to hyperion 7f pb 3.5h.A non-medtronic guide wire was crossed and an attempt was made to aspirate using a non-medtronic aspiration catheter, but resistance was felt in the stented proximal region, and it failed to cross.Because there was a possibility of picking up the strut of the proximal region, wiring was performed again with the micro catheter.After the lesion was recrossed, the non-medtronic aspiration catheter was used again to pass and aspirate.Although stent deformation was not observed from ivus, isa was confirmed at the ostium.Post-dilation was performed with a non-medtronic nc balloon (4.0 x 8mm).After waiting for 10 minutes an angiograph was performed however the thrombus image increased and poba was performed again and waited for 10 minutes.8000 units of heparin was administered, however, as the activated coagulation time (act) was not sufficiently prolonged to 232 seconds, it was suggested that there was a possibility of the thrombus being caused by heparin-induced thrombocytopenia (hit), 10 mg of slonnon was administered.It was also suggested that the slight gap might be related to the at.

Manufacturer Narrative

Additional info: there was slight tortuosity and calcification at the target lesion.After post-dilation the proximal region of stent was floating.Incomplete stent apposition was confirmed at the ostium.It was assessed that there was no relevant patient medical history that may have made the patient more prone to a thrombolytic event.It was assessed that thrombosis might occur due to the malapposition, and it was strange that thrombosis was caused by this degree of apposition.Post procedure, the patient recovered smoothly.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: 8270773
• MDR Text Key: 133860510
• Report Number: 9612164-2019-00283
• Device Sequence Number: 1
• Product Code: NIQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 02/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/02/2020
• Device Catalogue Number: RONYX30026JX
• Device Lot Number: 0009125837
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 01/23/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 02/19/2019
• Date Device Manufactured: 05/03/2018
• 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
• Patient Age: 72 YR