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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
Model Number RONYX35018UX
Device Problems Activation, Positioning or Separation Problem (2906); Mechanical Jam (2983)
Patient Problem Hematoma (1884)
Event Date 07/21/2020
Event Type  malfunction  
Event Description
Patient's status post percutaneous coronary intervention (pci) of saphenous vein grafts (svg) to patent ductus arteriosus (pda).Complicated by undelpoyed stent stuck in the soft tissue in the groin, needed manual pressure.Cross over angio did not show any complications.Hematoma after sitting up and eating now under control, pressure applied for 30 min.Fem stop applied with no pressure, distal pulses well felt.
 
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Brand Name
RESOLUTE ONYX
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
MEDTRONIC, INC.
710 medtronic parkway
minneapolis MN 55432
MDR Report Key10378475
MDR Text Key202049548
Report Number10378475
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier00643169557086
UDI-Public(01)00643169557086
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 07/22/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2020
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberRONYX35018UX
Device Catalogue Number(240)RONYX35018UX
Device Lot Number(10)0010251213
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/22/2020
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA07/22/2020
Event Location Hospital
Date Report to Manufacturer08/07/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age25185 DA
Patient Weight40
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