• 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 ALPINE 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 ALPINE EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1120250-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Thrombosis/Thrombus (4440)
Event Date 03/12/2024
Event Type  Injury  
Event Description
It was reported that the procedure was to treat a lesion in the left anterior descending (lad) and proximal left circumflex (plcx) with 90% stenosis, mild calcification and mild tortuosity.The patient's left ventricular ejection fraction (lvef) was 48%.The plcx was treated with 2.5x15mm xience alpine stent at 16 atmospheres (atms) and post dilated with 2.5x12mm nc trek balloon.The lad was treated with 2.75x38 xience alpine stent at 16 atms and post dilated with 2.75x20mm nc trek balloon at 18 atms.Post dilatation was performed per standard procedure.Timi 3 flow was achieved.There was no adverse patient effect and there was no clinically significant delay in the procedure.However, on 03/12/2024, the patient came back with chest pain and both vessels where the stents were implanted confirmed blockage on coronary artery angiography (cag).Electrocardiogram (ecg) and troponin test was performed for the chest pain.Occlusion was confirmed to be thrombosis.Patient was referred for coronary artery bypass grafting (cabg) and unknown when it will be performed.No additional information was provided.
 
Manufacturer Narrative
The device was not returned for analysis.Lot history record (lhr) and exception reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint history identified no similar incidents from this lot.The reported patient effects of thrombosis and angina are listed in the xience alpine everolimus eluting coronary stent system (eifu), electronic instructions for use (eifu), as a known patient effect of coronary stenting procedures.A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional xience alpine device(s) referenced in b5 is/are filed under separate medwatch report number(s).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
XIENCE ALPINE 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 Key19139628
MDR Text Key340563093
Report Number2024168-2024-04852
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648205514
UDI-Public(01)08717648205514(17)250126(10)2011941
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
Report Date 04/18/2024
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 Number1120250-15
Device Lot Number2011941
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/27/2024
Initial Date FDA Received04/18/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/27/2022
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) Hospitalization;
-
-