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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC, INC. RESOLUTE ONYX; CORONARY DRUG-ELUTING STENT
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MEDTRONIC, INC. RESOLUTE ONYX; CORONARY DRUG-ELUTING STENT Back to Search Results
Catalog Number RONYX22534UX
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Code Available (3191)
Event Date 08/31/2017
Event Type  malfunction  
Event Description
Stent was in the body, became disconnected from the balloon delivery system.Md had to insert snare and remove stent undeployed.Per supervisor: all parts retrieved from patient.Device sequestered if risk requires, otherwise we will return to vendor for review.We have had 3 issues over the last month with these types of stents.Last week where doctor deployed the stent and tried to post dilated with the stent balloon but it would not inflate and then eventually did and burst.No harm to the patient.No info on other 2 anecdotal events.Reviewed with physicians and they feel comfortable still using this product.
 
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Brand Name
RESOLUTE ONYX
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC, INC.
3576 unocal pl
santa rosa CA 95403
MDR Report Key6958110
MDR Text Key89623154
Report Number6958110
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/27/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2017
Is this a Product Problem Report? Yes
Device Operator No Information
Device Catalogue NumberRONYX22534UX
Device Lot Number8471150
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/27/2017
Event Location Other
Date Report to Manufacturer09/27/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age90 YR
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