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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ABBOTT VASCULAR XIENCE PROS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM

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ABBOTT VASCULAR XIENCE PROS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1508300-15
Device Problems Material Rupture (1546); Improper or Incorrect Procedure or Method (2017); Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/25/2022
Event Type  Injury  
Event Description
It was reported that the procedure was to treat an unspecified artery. The 3. 0x15mm xience pros stent was successfully implanted with no resistance during advancement. However, during implantation, it was noted that the pressure in the balloon which was inflated once with a pressure of 14 atmospheres (atms) was not maintained during dilatation. The stent was post dilated with a nc balloon because of the unsafe expansion of the stent and the inflation pressure during stent implantation that was not safely maintained. After removal of the balloon and upon inspection, it was noticed that there was a small hole from which the contrast medium could escape. The device was not prepped (air aspiration) outside the anatomy prior to use. There was no reported adverse patient effect and there was no clinically significant delay in the procedure. No additional information are required.
 
Manufacturer Narrative
The device is expected to be returned for investigation. It has not yet been received. A follow-up report will be submitted with all additional relevant information. Device code: 2017 clarifier, incorrect prep. The xience pros device is currently not commercially available in the us; however, it is similar to a device sold in the usa.
 
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Brand NameXIENCE PROS EVEROLIMUS ELUTING CORONARY STENT 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 Key14142219
MDR Text Key289511148
Report Number2024168-2022-04189
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeGM
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
Type of Report Initial
Report Date 04/19/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/19/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1508300-15
Device Lot Number1100441
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/28/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2021
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: 04/19/2022 Patient Sequence Number: 1
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