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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
Catalog Number RONYX30030UX
Device Problem Activation, Positioning or SeparationProblem (2906)
Patient Problem Unspecified Tissue Injury (4559)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Journal: texas heart institute journal title: triple-guidewire technique for treating stent underexpansion in severely calcified coronary artery lesions. Reference: doi. Org/10. 14503/thij-18-6622. Date of event: date of publication. If information is provided in the future, a supplemental report will be issued.
 
Event Description
A case report was submitted titled; triple-guidewire technique for treating stent underexpansion in severely calcified coronary artery lesions. A patient presented with substernal angina and associated shortness of breath of one month¿s duration. An ecg revealed new st-segment depressions. A coronary angiogram revealed 90% stenosis of the proximal-to mid lcx, 80% of the distal lcx, 90% (calcified) of the proximal rca, and 70% (calcified) of the mid-to distal rca. During the staged procedure, a 3 × 30mm resolute onyx stent was guided across the proximal rca, with assistance from a 6f non medtronic guide extension catheter. The in-stent balloon was inflated at a pressure of 20 atm for 12 s but did not fully expand the stent, as revealed on the angiogram. A second, unsuccessful attempt was made to fully expand the stent by re-inflating the balloon at a pressure of 26 atm for 10 seconds. The in-stent balloon was then retracted and exchanged for a new 4x15-mm non medtronic non-compliant balloon. The balloon was inflated at pressures of 16 atm and 14 atm for 10 seconds each with no improvement. During another attempt using a non medtronic nc balloon and three non medtronic guidewires, and the balloon was inflated at a pressure of 26 atm for 10 seconds and the resolute onyx des was fully expanded with good angiographic results. At the 3-month follow-up visit, the patient reported having had no further episodes of angina or shortness of breath.
 
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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 Key11465661
MDR Text Key242663744
Report Number9612164-2021-00979
Device Sequence Number1
Product Code NIQ
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,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberRONYX30030UX
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/17/2021
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: 03/11/2021 Patient Sequence Number: 1
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