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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Model Number 1804400-18
Device Problems Deflation Problem (1149); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  malfunction  
Manufacturer Narrative
The stent 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.
 
Event Description
It was reported the procedure was to treat a heavily calcified, moderately tortuous lesion in the proximal left anterior descending artery. The 4. 0x18 mm skypoint stent delivery system (sds) was not prepared outside of the body. The (sds) was advanced to the target lesion without issue. The sds was inflated once to nominal pressure. During deflation negative pressure was held for several seconds, several times, the balloon did not fully deflate. When attempting to remove the sds, the sds got stuck in the guide catheter since the balloon was withdrawn partially deflated. The sds and guide catheter were removed as a single unit. A new guide catheter and non-compliant balloon was used to complete the procedure. There were no adverse patient effects and no reported clinically significant delay in the procedure. No additional information was provided.
 
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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 Key13811479
MDR Text Key288866970
Report Number2024168-2022-02838
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
Report Date 04/04/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804400-18
Device Catalogue Number1804400-18
Device Lot Number1082441
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/21/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/31/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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