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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 RONYX35038X
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem Vascular Dissection (3160)
Event Date 11/16/2019
Event Type  Injury  
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event Description
A resolute onyx drug eluting stent was used to treat a moderately tortuous, mildly calcified significant lesion in the distal left main - osteal left anterior descending - osteral left circumflex artery. There was no damage noted to the packaging. The device was inspected prior to use with no issues noted. Negative prep was not performed. Adequate ptca to lm - lad and lm - lcx was performed. The device did not pass through a previously deployed stent. Resistance was not encountered when advancing the device and excessive force was not used during delivery. It was reported that there were wire movement issues and there was difficulty loading or exchanging the guidewire. Following deployment of the 3. 5 x 38 mm resolute onyx, kissing balloon dilation was carried out in left main - left anterior descending and left main - left circumflex. It was reported that while extracting the wire from left main - left anterior descending, the wire broke in the left main resolute onyx stent although no force was used. It was thought this indicated that the 3. 5 x 38mm resolute onyx stent was now maldeployed, after the wire broke. It was reported the resolute onyx stent was previously deployed with high pressure. Attempts to retrieve the resolute onyx stent resulted in a dissection in the left main extending to the left anterior descending artery. Another stent was used to cover the left main - left anterior descending artery dissection. No other patient injury was reported.
 
Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Manufacturer Narrative
Additional information: a non-medtronic guidewire was used during the procedure. The non-medtronic wire detached into two pieces. Angiographically, the 3. 5 x 38mm resolute onyx had appeared well apposed to the vessel wall. It was reported the dissection was noted after stent deployment. The 3. 5 x 38mm resolute onyx was extracted from the patient with the broken wire. Correction: previously reported implant date not applicable as 3. 5 x 38mm resolute onyx was removed from the patient. If information is provided in the future, a supplemental report will be issued.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceSTENT, 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 Key9444903
MDR Text Key170081106
Report Number9612164-2019-05087
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeEG
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/04/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date12/20/2020
Device Catalogue NumberRONYX35038X
Device Lot Number0009502216
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/03/2020
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured12/21/2018
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/10/2019 Patient Sequence Number: 1
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