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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 1804275-18
Device Problems Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/27/2024
Event Type  malfunction  
Manufacturer Narrative
Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.
 
Event Description
It was reported that the procedure was to treat a lesion located in the 1st diagonal in the left anterior descending (lad) coronary artery that was heavily calcified.Reportedly, the nc trek neo rx 3.00 x 12mm was advanced first in the distal lad.Then, the xience skypoint des 2.75 x 18 rx us stent delivery system was unable to advance out of the guide catheter.The physician lost guide engagement and wire position, and pulled both devices into the guide catheter.Once the guide catheter was re-engaged, and the physician had wire placement, the nc trek neo was re-advanced into the distal lad (but not inflated).The sds was unable to advance, with resistance.Then the sds was removed and noticed that the stent had separated from the shaft outside the patient.The nc trek neo appeared to be kinked on the shaft.Both devices were not able to be used and set aside.A new stent and balloon of the same size were opened and successfully used.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
 
Manufacturer Narrative
The device was returned for analysis.The reported material separation was able to be confirmed.The reported difficult to advance was unable to be replicated in a testing environment due to the condition of the returned device.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.Additionally, a review of the complaint handling database identified no other similar incidents from this lot.As there was no damage noted to the device during the inspection prior to use.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the guiding catheter and/or other devices resulted in the reported difficult to advance.Manipulation of the device resulted in the noted device damages (torn guide wire exit notch, multiple hypotube bends/kinks) further contributing to the reported difficult to advance and ultimately resulted in the reported/noted material separation.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
 
Event Description
Subsequent to the initial report being filed, the reported details were reviewed and it was been noted that the separation was reported to be at the shaft/hypotube.There was no stent separation.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 Key18899111
MDR Text Key337620135
Report Number2024168-2024-03291
Device Sequence Number1
Product Code NIQ
UDI-Device Identifier08717648233166
UDI-Public(01)08717648233166(17)260620(10)3062841
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,Followup
Report Date 06/06/2024
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 Catalogue Number1804275-18
Device Lot Number3062841
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/27/2024
Initial Date FDA Received03/13/2024
Supplement Dates Manufacturer Received06/04/2024
Supplement Dates FDA Received06/08/2024
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/21/2023
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
NC TREK NEO 3.0X12MM.
Patient Age74 YR
Patient SexMale
Patient Weight95 KG
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