• 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
Catalog Number 1500300-38
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Enzyme Elevation (1838); Occlusion (1984); Prolapse (2475)
Event Date 10/22/2020
Event Type  Injury  
Manufacturer Narrative
The device was not returned for evaluation. 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 prolapse and occlusion are listed in the xience sierra everolimus eluting coronary stent systems instructions for use (ifu) as a known patient effects of coronary stenting procedures. A conclusive cause for the reported patient effect(s), and the relationship to the product, if any, cannot be determined. However, the 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
Patient id: (b)(6). It was reported that the procedure was performed to treat a lesion in the proximal left anterior descending (lad) artery. The 3. 0 x 38 mm xience sierra stent delivery system was advanced and the stent was implanted. Post implant, angiography noted plaque prolapse and addition post dilatation was performed. The plaque prolapse was resolved with post dilatation. Post procedure, enzyme elevation was noted and was deemed related to occlusion of a small diagonal branch. The patient remained asymptomatic and no intervention was performed. The event resolved three days post procedure. 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 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 Key10869996
MDR Text Key217176526
Report Number2024168-2020-09757
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIT
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
Report Date 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/19/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number1500300-38
Device Lot Number0071541
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 Received10/30/2020
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 11/19/2020 Patient Sequence Number: 1
-
-