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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 1804350-38
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Arrhythmia (1721); Bradycardia (1751)
Event Date 04/24/2023
Event Type  Injury  
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.A conclusive cause for the reported patient effect(s), 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.The reported patient effect of arrhythmia is listed in the xience skypoint everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary stenting procedures.There is no indication of a product quality issue with respect to manufacture, design or labeling.
 
Event Description
It was reported that the procedure was to treat mildly calcified, 95% stenosed lesions in the left anterior descending (lad), right coronary (rca) and diagonal (left coronary) arteries.On (b)(6) 2023, the patient had 7 xience skypoint drug eluting stents (des) implanted without issue.A 4.5x33mm and 4.5x18mm stents were placed in the rca.A 3.0x38mm, 3.5x38mm and 3.5x8mm stents were placed in the lad.A 2.5x18mm and 2.5x8mm stents were placed in the diagonal artery.On (b)(6)2023, the patient presented to a different physician experiencing constant arrhythmias throughout the day and bradycardia with heart rates of 32-35 beats per minute (bpm).The patient was asymptomatic prior to his procedure on 3/24/2023.Additional treatment has not yet been provided.There was no adverse patient sequela and no reported clinically significant delay in the procedure or therapy.No additional information was provided.
 
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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 Key17035767
MDR Text Key316287462
Report Number2024168-2023-05698
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648233449
UDI-Public08717648233449
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 Physician
Type of Report Initial
Report Date 05/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number1804350-38
Device Catalogue Number1804350-38
Device Lot Number2072641
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/09/2023
Initial Date FDA Received06/01/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/03/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age73 YR
Patient SexMale
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