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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE ONYX RX; STENT, CORONARY, DRUG-ELUTING Back to Search Results
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.
 
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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 Key8270773
MDR Text Key133860510
Report Number9612164-2019-00283
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P160043
Number of Events Reported1
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 Date05/02/2020
Device Catalogue NumberRONYX30026JX
Device Lot Number0009125837
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/15/2019
Initial Date FDA Received01/23/2019
Supplement Dates Manufacturer Received01/24/2019
Supplement Dates FDA Received02/19/2019
Date Device Manufactured05/03/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age72 YR
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