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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
Catalog Number 1800300-08
Device Problems Entrapment of Device (1212); Malposition of Device (2616); Device Dislodged or Dislocated (2923)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 11/23/2022
Event Type  Injury  
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.The additional xience skypoint device referenced is filed under separate medwatch report number.
 
Event Description
It was reported that the procedure was to treat a distal right coronary artery (rca).A 3x18mm xience skypoint stent was implanted first without issue in the mid rca.Due to residual distal stenosis noted after the first stent was implanted [not within the first stent but in the distal bed], a 3x8mm xience skypoint was decided to be implanted distal to the first one.The xience skypoint was being advanced through the first stent without resistance when it was noted that the stent implant of the 3x8mm xience skypoint slid off the balloon and remained fixed on the previous stent.It was not possible to remove the second xience skypoint stent (thought to be due to being caught with the first stent).Therefore it was decided to deploy the second stent where it was by using a non-compliant balloon to crush the stent implant over the first one.There were no adverse patient sequela and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was not returned for analysis.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents/complaints from this lot.The investigation determined the reported difficulties and subsequent treatment appear to be related to the operational context of the procedure.In this case, it was reported that the stent delivery system was advanced through a previously implanted stent.It is likely that the reported stent interacted with the previously implanted stent during advancement, resulting in the reported entrapment of device (stent).Additionally, it is likely that the interaction with the implanted stent resulted in the reported stent dislodgement.The dislodged stent was crushed against the previously implanted stent using a balloon, resulting in the reported malposition of device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.Na.
 
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Brand Name
XIENCE SKYPOINT DRUG ELUTING CORONARY STENT DELIVERY SYSTEM
Type of Device
DRUG 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 Key15983426
MDR Text Key305490256
Report Number2024168-2022-12644
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeLU
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 Physician
Type of Report Initial,Followup
Report Date 01/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1800300-08
Device Lot Number2062141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/06/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/15/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
3X18MM XIENCE STENT; GUIDEWIRE BMW
Patient Outcome(s) Required Intervention;
Patient Age81 YR
Patient SexFemale
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