• 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 1550350-28
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Non specific EKG/ECG Changes (1817); Thrombosis (2100); Ventricular Tachycardia (2132)
Event Date 12/04/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4). The incident information was reviewed; however, there was no reported device malfunction and the product was not returned as the stent remains in the anatomy. The reported patient effect of thrombosis is listed in the xience sierra everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures. A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event. Based on the case information and related record review, a conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined and the treatment appears to be related to the circumstances of the procedure. There is no indication of a product quality issue with respect to design, manufacture or labeling of the device.
 
Event Description
It was reported that the patient presented with an acute st elevated myocardial infarction and the procedure was to treat a concentric, de novo lesion in the mid right coronary artery with no tortuosity, no calcification and 99% stenosis. Following thrombus aspiration and pre-dilatation with a 2. 0 mm unspecified balloon, a 3. 50 x 28 mm xience sierra stent was deployed at 12 atmospheres for 20 seconds. Post -dilatation of the stent was completed at 16 atmospheres for 20 seconds with an unspecified balloon catheter. Intravascular ultrasound and angiography were completed post stenting and timi flow grade was 3. Post procedure, the patient was transferred to their room for recovery with a heparin dose of 5000 units; however, changes on electrocardiograph were noted. A further angiography confirmed in-stent thrombosis. The patient was treated with an intra-aortic balloon pump, further lesion dilatation with an unspecified balloon and aspiration of the thrombus. The patient was being followed up on an inpatient basis. 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)
CLONMEL, IRELAND REG# 9616693
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 Key8187630
MDR Text Key131127799
Report Number2024168-2018-09971
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Remedial Action Other
Type of Report Initial
Report Date 12/20/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/20/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/25/2021
Device Catalogue Number1550350-28
Device Lot Number8031241
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 Received12/04/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/01/2018
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: 12/20/2018 Patient Sequence Number: 1
-
-