• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT 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
 

AV-TEMECULA-CT XIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM Back to Search Results
Catalog Number 1500325-18
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Cardiac Enzyme Elevation (1838); Occlusion (1984); Thrombosis (2100); Prolapse (2475)
Event Date 01/01/2019
Event Type  Death  
Manufacturer Narrative
(b)(4). During processing of this complaint, attempts were made to obtain complete event, patient and device information. The stent remains in the patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The 3. 0x38 xience sierra stent referenced is filed under mfr report # 2024168-2019-01440.
 
Event Description
It was reported that on (b)(6) 2018, two xience sierra stents (3. 0x38mm, 3. 25x18mm) were implanted in the proximal left anterior descending artery. Post procedure, cardiac enzymes were elevated. The patient was discharged home on (b)(6) 2019. After discharge, on (b)(6) 2019, the patient died, likely due to thrombosis of the implanted xience sierra stents. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG ELUTING CORONARY STENT SYSTEM
Manufacturer (Section D)
AV-TEMECULA-CT
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer (Section G)
ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168
abbott vascular
26531 ynez road
temecula CA 92591 4628
Manufacturer Contact
connie speck
abbott vascular
26531 ynez road
temecula, CA 92591-4628
9519143996
MDR Report Key8442192
MDR Text Key139529292
Report Number2024168-2019-02236
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,study
Reporter Occupation
Remedial Action Other
Type of Report Initial,Followup
Report Date 04/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1500325-18
Device Lot Number8062041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/17/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 03/21/2019 Patient Sequence Number: 1
Treatment
XIENCE SIERRA 3.0X38MM
-
-