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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 1508350-28
Device Problems Difficult to Remove (1528); Material Separation (1562)
Patient Problem Hypoxia (1918)
Event Date 05/24/2022
Event Type  Injury  
Manufacturer Narrative
The device has returned for investigation. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The xience pros device is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
Event Description
It was reported the procedure was to treat a left anterior descending artery. The 3. 5x28mm xience pros stent delivery system (sds) was deployed successfully; however, during removal resistance was noted and the sds shaft separated. The separated portion could not be retrieved when attempting to remove the device, therefore, the patient had to be transferred to the heart surgery department where the separated portion was recovered via open surgery. After surgery the patient had to be connected to the heart-lung machine [ventilator] which is still ongoing. There was no clinically significant delay reported. No additional information was provided.
 
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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 Key14697045
MDR Text Key294037398
Report Number2024168-2022-06411
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,Followup
Report Date 08/03/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1508350-28
Device Lot Number1042041
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received07/20/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/26/2021
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: 06/15/2022 Patient Sequence Number: 1
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