• 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 SKYPOINT 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 SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1804300-28
Device Problems Improper or Incorrect Procedure or Method (2017); Difficult to Advance (2920)
Patient Problems Angina (1710); Cardiac Arrest (1762); Non specific EKG/ECG Changes (1817); Respiratory Failure (2484); Thrombosis/Thrombus (4440)
Event Date 01/05/2022
Event Type  Death  
Manufacturer Narrative
The clip remains in patient. The device will not be returned for evaluation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. Na.
 
Event Description
It was reported that on (b)(6) 2022, a procedure was performed to treat the bifurcation of the left anterior descending (lad) artery. Three xience skypoint's were deployed without issues. An additional skypoint was attempted to be inserted, but the physician noticed the stent became damage while pushing through the tuohy. Therefore, the stent was removed and a balloon was inserted in an attempt to pass through the most proximal implanted stent. However, the balloon was unable to pass through the stent and after roughly 30 minutes, it was observed the implanted stent had become completely occluded. Clots were then observed at the occluded stent and in the left main. It was noted no clotting occurred near the other two implanted stents. Additional heparin was then administered. Aspiration was performed and the clot was successfully removed. However, the st elevation increased and the patient started to have chest pains. The patient then became unresponsive and chest compressions were performed. The patient was intubated and left the operating room on a ventilator. On (b)(6) 2022, the patient passed away. No additional information was provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameXIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY 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 Key13344453
MDR Text Key284832070
Report Number2024168-2022-00828
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 04/27/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/25/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804300-28
Device Catalogue Number1804300-28
Device Lot Number1032241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/19/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/29/2021
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: 01/25/2022 Patient Sequence Number: 1
Treatment
IMPLANTED XIENCE SKYPOINT (X2)
-
-