Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ABBOTT VASCULAR XIENCE XPEDITION EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1070400-33
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombosis/Thrombus (4440)
Event Date 06/21/2023
Event Type  Death  
Event Description
It was reported that the patient presented with left main (lm) ostial disease and the procedure was to treat a lesion in the lm artery with moderate calcification.The 4.0x33mm xience xpedition stent was implanted from lm to the left anterior descending (lad) artery.Post implantation, acute stent thrombosis occurred in the lm and the patient's blood pressure fell.The patient died on the table.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.
 
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The reported patient effects of hypotension, thrombosis and death are listed in the xience xpedition everolimus eluting coronary stent systems instructions for use as known patient effects of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent treatment appears to be related to the operational context of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the patient presented with left main (lm) ostial disease and the procedure was to treat a lesion in the lm artery with moderate calcification.The 4.0x33mm xience xpedition stent was implanted from lm to the left anterior descending (lad) artery.Post implantation, acute stent thrombosis occurred in the lm and the patient's blood pressure fell.The patient died on the table.Subsequent to the initially filed report, the following information was provided: the patient presented with chronic stable angina.Angiography was performed to confirm stent thrombosis.The hypotension was related to the device and was treated with atropine and noradrenaline but did not resolve.The patient died on the table while thrombosuction was being performed.In the physician's opinion, the xience xpedition caused or contributed to the thrombus and death.No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key17400495
MDR Text Key319806374
Report Number2024168-2023-08065
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
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 08/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number1070400-33
Device Lot Number2042041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/22/2023
Initial Date FDA Received07/26/2023
Supplement Dates Manufacturer Received08/09/2023
Supplement Dates FDA Received08/18/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/27/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age66 YR
Patient SexFemale
-
-