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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 1070275-38
Device Problems Stretched (1601); Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
Event Type  malfunction  
Manufacturer Narrative
The device was returned for analysis. The reported material deformation and shaft stretching were confirmed. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Additionally, a review of the complaint history identified no other incidents from this lot. The investigation cannot determine a conclusive cause for the reported material deformation; however, factors that could contribute to material deformation include, but are not limited to, interaction with accessory devices, interaction with difficult anatomy and product damage during handling by user. The reported shaft stretching appears to be related to operational context as it is likely handling and/or manipulation of the device during the procedure caused the reported shaft stretching. There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat a mildly calcified, mildly tortuous left anterior descending artery. The 2. 75x38mm xience xpedition was noted to have flared stent struts and the shaft was stretched during the procedure. Another same size device was used to successfully complete the procedure. There was no adverse patient effects and no clinically significant delay. No additional information was provided.
 
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Brand NameXIENCE XPEDITION 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 Key13052160
MDR Text Key282557618
Report Number2024168-2021-11947
Device Sequence Number1
Product Code NIQ
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
Reporter Occupation
Type of Report Initial
Report Date 12/21/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1070275-38
Device Lot Number0060341
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/11/2020
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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