• 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 1804325-15
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Angina (1710); Heart Failure/Congestive Heart Failure (4446)
Event Date 02/06/2022
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 effect of angina is listed in the xience skypoint, everolimus eluting coronary stent system (eecss), electronic instructions for use as a known patient effect of coronary stenting procedures. A conclusive cause for the reported patient effects, and the relationship to the product, if any, cannot be determined; however, the subsequent 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 of the device.
 
Event Description
It was reported that on (b)(6) 2022 the patient had a 3. 25x15mm xience skypoint stent implanted. On (b)(6) 2022 the patient was re-hospitalized due chest pain, hypertensive heart/heart failure. There was no treatment reported and there was no adverse patient sequela or clinically significant delay. 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 Key14149509
MDR Text Key289616356
Report Number2024168-2022-04230
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 Other,Health Professional
Reporter Occupation
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number1804325-15
Device Catalogue Number1804325-15
Device Lot Number1052041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/26/2021
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: 04/19/2022 Patient Sequence Number: 1
-
-