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U.S. Department of Health and Human Services

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

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MEDTRONIC IRELAND RESOLUTE ONYX RX CORONARY DRUG-ELUTING STENT Back to Search Results
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/10/2020
Event Type  malfunction  
Manufacturer Narrative
Journal article: intravascular imaging to guide lithotripsy in concentric and eccentric calcific coronary lesions authors: alessio mattesini, giulianardi, antonio martellini, carlotta sorini dini, brunilda hamiti, miroslava stolcova, francesco meucci, carlo di mario journal: cardiovascular revascularization medicine year: 2020 reference: doi. Org/10. 1016/j. Carrev. 2020. 04. Average age. Majority gender. Date of publication patient death was also included in the results of the journal article, however no causal link suggesting that the medtronic device used in the patient cohort may have caused or contributed to the death was provided. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A journal article titled: intravascular imaging to guide lithotripsy in concentric and eccentric calcific coronary lesions - was submitted for review. The aim of this prospective registry is the evaluation of the immediate procedural success and complications, in a real-world consecutive group, of highly coronary calcific lesions (ccls) treated following a specific algorithm of selection for intravascular lithotripsy (ivl) based on intravascular imaging with optical coherence tomography (oct) or intravascular ultrasound (ivus). A total of 31 calcified lesions in 28 patients were treated with ivl, followed by oct/ivus guided stent implantation with either a resolute onyx coronary drug eluting stent or other non-medtronic des. Intra operative complications included one dissection requiring an additional stent implantation and three peri-procedural myocardial infarctions (mi). Clinical outcomes at 30 days showed one sudden death on day 10, likely due to a cerebral hemorrhage. Intracoronary imaging findings detected significant stent malapposition. Overall, this study found that lesions treated with ivl followed by ivus/oct guided second generation des implantation delivered excellent immediate procedural results and short-term patient outcome, both in concentric or eccentric calcifications.
 
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Brand NameRESOLUTE ONYX RX
Type of DeviceCORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer (Section G)
MEDTRONIC IRELAND
parkmore business park west
galway
EI
Manufacturer Contact
toni o'doherty
parkmore business park west
galway 
EI  
091708734
MDR Report Key11854379
MDR Text Key251702596
Report Number9612164-2021-01990
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
P160043
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
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 Received07/28/2021
Was Device Evaluated by Manufacturer? No Answer Provided
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: 05/20/2021 Patient Sequence Number: 1
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