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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 1804350-18
Device Problem Material Separation (1562)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/04/2021
Event Type  malfunction  
Manufacturer Narrative
The device was received. 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 mildly calcified left anterior descending artery. The 3. 5x18mm xience skypoint stent delivery system (sds) was advanced and deployed without issue; however, during removal of the sds the tip separated in the guide catheter. The separated portion was removed with the unspecified guide catheter. There were no adverse patient effects and no clinically significant delay. 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 Key12978869
MDR Text Key287922036
Report Number2024168-2021-11433
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 01/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number1804350-18
Device Catalogue Number1804350-18
Device Lot Number1061541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/22/2021
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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