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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDTRONIC MEDTRONIC; EVERFLEX PROTEGE, SELF-EXPANDING PERIPHERAL STENT SYSTEM

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MEDTRONIC MEDTRONIC; EVERFLEX PROTEGE, SELF-EXPANDING PERIPHERAL STENT SYSTEM Back to Search Results
Model Number PRB35-06-120-120
Device Problem Physical Resistance/Sticking (4012)
Patient Problem Tissue Damage (2104)
Event Date 03/25/2020
Event Type  Injury  
Event Description
Stent (protégé) implanted into pt's left arm av graft.During procedure, surgeon noticed that part of the stent was lodged in pt.Cutdown on the cephalic vein needed to remove stent insertion device.
 
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Brand Name
MEDTRONIC
Type of Device
EVERFLEX PROTEGE, SELF-EXPANDING PERIPHERAL STENT SYSTEM
Manufacturer (Section D)
MEDTRONIC
plymouth MN
MDR Report Key10876924
MDR Text Key219138207
Report Number10876924
Device Sequence Number1
Product Code NIP
UDI-Device Identifier00821684059968
UDI-Public(01)00821684059968(17)2
Combination Product (y/n)Y
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 03/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date04/11/2021
Device Model NumberPRB35-06-120-120
Device Catalogue NumberPRB35-06-120-120
Device Lot NumberA628708
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA03/26/2020
Distributor Facility Aware Date03/26/2020
Event Location Hospital
Date Report to Manufacturer03/26/2020
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age63 YR
Patient Weight66
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