• 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 1804250-18
Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/10/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device will not be returned for evaluation, the device was reportedly discarded. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information.
 
Event Description
It was reported that the procedure was to treat a heavily calcified, moderately tortuous unspecified lesion. The 2. 5x18mm xience skypoint stent delivery system (sds) failed to cross due to anatomy. After balloon dilatation was performed the sds was advanced; however, the sds failed to cross. Resistance with anatomy was also noted during removal. Another non-abbott stent was used to successfully complete the procedure. There was no adverse patient effects and no clinically significant delay reported. 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 Key13043429
MDR Text Key282498218
Report Number2024168-2021-11866
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeJA
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804250-18
Device Catalogue Number1804250-18
Device Lot Number0102041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/29/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/27/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-