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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE PRIME LL EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1011709-38
Device Problems Difficult to Remove (1528); Material Separation (1562); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/11/2021
Event Type  malfunction  
Manufacturer Narrative
Date of event estimated as (b)(6) 2021. The device was received. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
Return device analysis identified a hypotube separation. No information was reported on this complaint; however, no patient injury was reported. If additional information is received this will be re-evaluated for reportability.
 
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Brand NameXIENCE PRIME LL EVEROLIMUS ELUTING CORONARY 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 Key12682704
MDR Text Key278139206
Report Number2024168-2021-09513
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
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 11/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1011709-38
Device Lot Number1030441
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/30/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/10/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/09/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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