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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 1804325-15
Device Problems Loose or Intermittent Connection (1371); Activation Failure (3270); Noise, Audible (3273)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a left anterior descending artery.There was noted difficulty (resistance) connecting the xience skypoint to the indeflator and an abnormal noise was noted; however, it was able to be ultimately connected.The stent delivery system was then advanced to the lesion but completely failed to deploy.The device was replaced with another to successfully complete the procedure.There were no adverse patient effects 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 similar incidents from this lot.The investigation determined the reported difficulties appear to be related to operational circumstances of the procedure as it is likely the device interacted with the inflation device during connection due to an inadvertent over torque of the inflation device causing the reported audible noise and loose or intermittent connection.The reported loose or intermittent connection between the delivery system and the inflation device likely prevented the delivery system from inflating causing the reported activation failure.There is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
 
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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 Key12790908
MDR Text Key281591609
Report Number2024168-2021-10225
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648233319
UDI-Public08717648233319
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,Distributor
Reporter Occupation Physician
Type of Report Initial
Report Date 11/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/14/2023
Device Model Number1804325-15
Device Catalogue Number1804325-15
Device Lot Number0091041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 10/28/2021
Initial Date FDA Received11/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/15/2020
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
(MERIT MEDICAL) INDEFLATOR
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