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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 1070225-15
Device Problems Difficult to Advance (2920); Material Deformation (2976); Material Twisted/Bent (2981); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/07/2023
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat the diagonal coronary artery with 90% stenosis.The 2.25x15 mm xience xpedition stent delivery system (sds) was advanced with resistance noted with another unspecified device which was present at the lesion.The stent mesh/struts were noted to be damaged after advancing through the lesion and the sds was then removed.There were no adverse patient effects and there was no clinically significant delay in the procedure.Returned device analysis identified that the shaft of the device was bunched and torn 4mm proximal to the guidewire exit notch for a length of 2mm.Follow-up with the site confirmed they were aware of the damage no additional information was provided.
 
Manufacturer Narrative
Facility name: (b)(6).Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
 
Manufacturer Narrative
The device was returned for analysis.The reported material deformation, bent shaft, and torn shaft were confirmed.The reported difficulty to advance could not be replicated in a testing environment as it was related to operational context of the procedure.Lot history record (lhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no other incidents from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
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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 Key19014942
MDR Text Key339082121
Report Number2024168-2024-04001
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648158476
UDI-Public(01)08717648158476(17)251027(10)2110241
Combination Product (y/n)Y
Reporter Country CodeBR
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 04/22/2024
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 Number1070225-15
Device Lot Number2110241
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2024
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/13/2024
Initial Date FDA Received04/01/2024
Supplement Dates Manufacturer Received04/09/2024
Supplement Dates FDA Received04/22/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2022
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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