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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PRIME BTK EVEROLIMUS ELUTING PERIPHERAL STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE PRIME BTK EVEROLIMUS ELUTING PERIPHERAL STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1012650-38
Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920); Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 10/18/2021
Event Type  Injury  
Manufacturer Narrative
The device was received. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the 4. 0x38mm xience prime btk stent delivery system (sds) was attempted to advance over the. 014 unspecified guide wire; however, resistance was felt with the guide wire. When attempting to pull back the sds, the shaft separated, which remained on the guide wire. It was noted resistance was also felt during removal with the guide wire. Additionally, the stent dislodged and migrated into the profunda femoral artery. The separated shaft portion was retrieved on the guide wire and the stent was left free floating. Patient is in good conditional and a follow up will be performed. There was no clinically significant delay in the procedure. No additional information was provided.
 
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Brand NameXIENCE PRIME BTK EVEROLIMUS ELUTING PERIPHERAL STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Manufacturer (Section D)
ABBOTT VASCULAR
26531 ynez rd.
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, REG # 3005718570 (P099)
cashel road
clonmel tipperary
EI
Manufacturer Contact
lindsey bell
26531 ynez rd.
temecula, CA 92591-4628
9519143996
MDR Report Key12787179
MDR Text Key280584375
Report Number2024168-2021-10197
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeFR
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date05/19/2022
Device Catalogue Number1012650-38
Device Lot Number0051342
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/09/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/20/2020
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: 11/10/2021 Patient Sequence Number: 1
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