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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 RONYX25015UX
Device Problems Inflation Problem (1310); Leak/Splash (1354)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/15/2018
Event Type  malfunction  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A resolute onyx device was intended to be used to treat a moderately tortuous, non-calcified lesion with 70% stenosis in the proximal lad.There was no damage noted to the device packaging.There were no issues when removing the device from the hoop.The device was inspected with no issues.Negative prep was not performed.The lesion was not pre-dilated.The device did not pass through a previously-deployed stent.No resistance was encountered when advancing the device.Excessive force was not used during delivery.It is reported that the tech heard the release of air coming from the hub when drawing negative.An attempt was made to reach nominal pressure when the device was in the patient, but a leak at the luer/hub was noted.Upon inability to inflate the balloon, the entire stent device was safely removed and placed on the sterile prep table.The device was replaced by another resolute onyx of the same lot.No patient injury is reported.
 
Manufacturer Narrative
Additional information reported that after positioning the stent at the lesion, the scrub tech drew negative.It was at that moment that the tech heard air seep out of the hub.The stent and balloon was removed effortlessly and without any risk to the patient.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Correction to aware date/date mfr rec for previously submitted additional information.The correct aware date for report # 96121 64-2018-01744 is the (b)(6) 2018.If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Device evaluation: kinks were evident on the hypotube from 51.5cm to 136cm proximal to the strain relief.The device returned with a detachment on the hypotube immediately distal to the strain relief.The hypotube material was oval and jagged on both sides of the detachment site.A make shift leur was attached to the hypotube at the detachment site, the balloon inflated at 12atm and the stent deployed.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 Key7689291
MDR Text Key114556168
Report Number9612164-2018-01744
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier00643169556805
UDI-Public00643169556805
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Physician
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 11/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date02/09/2020
Device Catalogue NumberRONYX25015UX
Device Lot Number0008988041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/02/2018
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 06/19/2018
Initial Date FDA Received07/16/2018
Supplement Dates Manufacturer Received07/16/2018
08/08/2018
09/21/2018
09/21/2018
11/27/2018
Supplement Dates FDA Received08/13/2018
10/03/2018
10/19/2018
11/22/2018
11/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/09/2018
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 Age56 YR
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