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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070300-15
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2023
Event Type  malfunction  
Event Description
It was reported that upon unpackaging of the 3x15mm xience xpedition stent delivery system (sds), the shaft was noted to be broken [separated].The sds was not used in the procedure.There was not patient involvement and no clinically significant delay reported in the procedure.Another stent was used to complete the procedure.No additional information was provided.
 
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
 
Event Description
Subsequent to the initial report, return device analysis found the stent delivery system (sds) was returned with blood in the balloon folds, in the guide wire lumen.There was contrast on the device.The procedure was to treat an 80% stenosed lesion in the left anterior descending (lad) artery.No additional information was provided.
 
Manufacturer Narrative
A visual inspection was performed on the returned device.The reported material separation was confirmed.A review of the production records was performed and revealed no related complaint assessment or manufacturing nonconformities.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported material separation.It was reported that the stent delivery system¿s shaft separated during removal from the dispenser.Factors that may contribute to a shaft separation during unpackaging include, but are not limited to, damage incurred during manufacturing, damage incurred during shipment, or inadvertent mishandling during unpacking or preparation.In this case, analysis of the returned device noted the fracture face of the separation to be oval.This type of damage is consistent with force applied at a kink or bend.It is possible that inadvertent mishandling during unpackaging contributed to the reported shaft separation and the noted inner/outer member damage.There is no indication of a product quality issue with respect to manufacture, design, or labeling.H6: patient code 2645 was removed and the patient code 2199 was added.
 
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Brand Name
XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of Device
DRUG 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 Key18983294
MDR Text Key338669468
Report Number2024168-2024-03703
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648157882
UDI-Public(01)08717648157882(17)250711(10)2070542
Combination Product (y/n)Y
Reporter Country CodeCH
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 05/14/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1070300-15
Device Lot Number2070542
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received03/26/2024
Supplement Dates Manufacturer Received05/10/2024
Supplement Dates FDA Received05/14/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/12/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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