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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 1800250-23
Device Problems Difficult or Delayed Activation (2577); Difficult to Advance (2920); Material Too Soft/Flexible (4007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/19/2021
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.
 
Event Description
It was reported that the procedure was to treat the proximal left anterior descending (lad) coronary artery. The 2. 50x23 mm xience skypoint stent delivery system was deployed at 16 atmospheres (atm) for 30 seconds; however, the stent was in an hourglass shape (pinched in the middle). Therefore a 2. 75x15 mm nc trek balloon dilatation catheter (bdc) was advanced with difficulty due to the previously implanted stent and inflated to 14 atm for almost 14 seconds. The stent was now well apposed and the procedure was completed. There were no adverse patient sequela reported and there was no reported clinically significant delay in the procedure. The physician also stated that the xience skypoint radial force is less than xience sierra. 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 Key12591665
MDR Text Key275219400
Report Number2024168-2021-09002
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeSA
PMA/PMN Number
P110019
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,distri
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/02/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1800250-23
Device Lot Number1060241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/11/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/25/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 10/07/2021 Patient Sequence Number: 1
Treatment
2.75X15 MM NC TREK BALLOON DILATATION CATHETER
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