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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 1070350-08
Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
Patient Problems Prolapse (2475); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/01/2023
Event Type  Injury  
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 lesion in the right coronary artery (rca) with heavy calcification and heavy tortuosity.The 3.5x8mm xience xpedition stent delivery system (sds) was advanced without issues; however, after a guidewire was inserted, all the calcification disappeared [plaque shift/dislocated].No additional stent was inserted.The patient was transferred to medication as the treatment.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.
 
Event Description
It was reported that the procedure was to treat a lesion in the right coronary artery (rca) with heavy calcification and heavy tortuosity.The 3.5x8mm xience xpedition stent delivery system (sds) was advanced without issues; however, after a guidewire was inserted, all the calcification disappeared [plaque shift/dislocated].No additional stent was inserted.The patient was transferred to medication as the treatment.There was no adverse patient effect and there was no clinically significant delay in the procedure.Subsequent to the initially filed report, the following information was provided: the xience skypoint stent was not used in the patient.After a guidewire was inserted, all the calcification disappeared and they did not insert the stent.There was no device use or patient involvement.No additional information was provided.
 
Manufacturer Narrative
A visual inspection was performed on the returned device.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.A review of the complaint history was not performed because the failure mode was not specified.The investigation was unable to determine a conclusive cause for the reported difficulties as a failure mode was not reported and there were no reported adverse patient effects.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Subsequent to the initially filed report, the following information was provided: the xience skypoint stent was not implanted at all.After a guidewire was inserted, all the calcification disappeared and they did not insert the stent.There was no device use or patient involvement.Based on the additional information received, this event would not have been reportable; however, since the initial report has already been filed, this event must remain reportable.H6: health effect - clinical code 2475 removed; 4582 added h6: health effect - impact code 4614 removed; 2645 added.H6: medical device problem code 2993 removed; 3189 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 Key17050410
MDR Text Key316413066
Report Number2024168-2023-05794
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJO
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 07/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Expiration Date12/13/2023
Device Catalogue Number1070350-08
Device Lot Number0120841
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/21/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/14/2020
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 Outcome(s) Other;
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