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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR INC. XIENCE XPEDITION; CORONARY DRUG-ELUTING STENT

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ABBOTT VASCULAR INC. XIENCE XPEDITION; CORONARY DRUG-ELUTING STENT Back to Search Results
Model Number 1070275-18
Device Problems Material Separation (1562); Failure to Advance (2524); Deformation Due to Compressive Stress (2889)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/27/2024
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
 
Event Description
It was reported that the procedure was to treat a de novo lesion located in the ostial circumflex arther that was both calcified and tortuous.An attempt was made to implant a xience xpedition des 2.75x18 rx stent delivery system failed to cross and the proximal shaft separated outside the patient.It is not known what replacement device was used to continue the procedure.However, there were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported deformation due to compressive stress was able to be confirmed.The reported failure to advance was unable to be replicated in a testing environment as it was based on operational circumstances.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a query of the complaint handling database for the reported lot revealed there is no indication of a lot level product quality issue.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that resistance was met with the calcified and tortuous anatomy resulting in the reported failure to advance.Interaction and/or manipulation of the device resulted in the noted flared/stretched stent struts, the noted wrinkled inner/outer member and ultimately resulted in the reported deformation due to compressive stress/noted multiple hypotube bends.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.Corrections: h6 - medical device problem code 1562 was removed and code 2889 was added.
 
Event Description
It was reported that the procedure was to treat a de novo lesion located in the ostial circumflex arther that was both calcified and tortuous.An attempt was made to implant a xience xpedition des 2.75x18 rx stent delivery system failed to cross and the proximal shaft separated outside the patient.It is not known what replacement device was used to continue the procedure.However, there were no reported adverse patient effects and no clinically significant delay in the procedure.Subsequently, after the initial report was filed the following information was received: the 2.75x18mm xience xpedition did not separate.The hypotube was kinked.No additional information was provided.
 
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Brand Name
XIENCE XPEDITION
Type of Device
CORONARY DRUG-ELUTING STENT
Manufacturer (Section D)
ABBOTT VASCULAR INC.
3200 lakeside drive
santa clara CA 95054 2807
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 Key19126398
MDR Text Key340678991
Report Number2024168-2024-04772
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648157790
UDI-Public(01)08717648157790(17)260426(10)3050841
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 06/27/2024
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 Model Number1070275-18
Device Catalogue Number1070275-18
Device Lot Number3050841
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/01/2024
Initial Date FDA Received04/17/2024
Supplement Dates Manufacturer Received06/17/2024
Supplement Dates FDA Received06/27/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/27/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient SexMale
Patient Weight82 KG
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