• 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 SIERRA 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 SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1550300-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Cardiac Enzyme Elevation (1838); Stenosis (2263); Test Result (2695)
Event Date 12/31/2019
Event Type  Injury  
Manufacturer Narrative
The stent remains in the patient. Investigation is not yet complete. A follow up report will be submitted with all additional relevant information.
 
Event Description
Patient id: (b)(6). It was reported that on (b)(6) 2019, a percutaneous coronary intervention was performed on the right coronary artery (rca), 95% stenosed lesion. A 3. 0x15mm xience sierra stent (1550300-15, 9011441) was implanted in the distal rca without complication. Following, a 3. 0x18 and a 3. 5x18mm xience sierra stent were implanted in the mid rca without complication. Acceptable results were noted as the rca was observed with timi flow iii and 0% diameter stenosis following stent implantation. On (b)(6) 2019, the patient experienced worsening jaw pain and a positive non-stress test was noted. The patient was admitted to the hospital with coronary artery disease. Another cardiac catheritization was performed and target vessel disease was observed. 80% proximal lad stenosis, 99% distal lcx stenosis, 99% proximal rca stenosis, widely patent stent (stent not specified), and 70% distal rca stenosis. On (b)(6) 2020, a coronary artery bypass graft (cabg) was performed in the lad, om and pda. Elevated troponin was noted following. The event resolved without sequela. No additional information was provided regarding this issue.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXIENCE SIERRA EVEROLIMUS ELUTING CORONARY STENT SYSTEM
Type of DeviceDRUG 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 Key10261450
MDR Text Key198529295
Report Number2024168-2020-05693
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
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
Type of Report Initial,Followup
Report Date 08/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/20/2020
Device Model Number1550300-15
Device Catalogue Number1550300-15
Device Lot Number9011441
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 Received08/19/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/21/2019
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: 07/10/2020 Patient Sequence Number: 1
-
-