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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT SYSTEM; DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1128400-12
Device Problems Failure to Advance (2524); Device Dislodged or Dislocated (2923)
Patient Problem Foreign Body In Patient (2687)
Event Date 01/19/2024
Event Type  Injury  
Event Description
It was reported that the procedure was to treat a moderately calcified, moderately tortuous left anterior descending artery (lad).A non-abbott guide wire was passed through the distal lad.The vessel was pre-dilated with 4.0x13mm scoring balloon.A 4.0x12mm xience proa stent was attempted to cross the lesion; however, the stent dislodged at the proximal lad.Therefore, two unspecified 1.25x15mm and 2.0x10mm balloons were used in an attempt to embed the dislodged the stent in the femoral artery.A 4.0x13mm non-abbott were used to complete the procedure.There was no clinically significant delay reported.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 other incidents from this lot.The investigation determined the reported difficulties and treatment appear to be related to circumstances of the procedure.There is no indication of a product quality issue with respect to manufacture, design or labeling.The xience proa device is currently not commercially available in the us; however, it is similar to a device sold in the us.
 
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Brand Name
XIENCE PROA EVEROLIMUS ELUTING CORONARY STENT 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 Key18699084
MDR Text Key335293696
Report Number2024168-2024-01768
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeTH
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 Physician
Type of Report Initial
Report Date 02/13/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1128400-12
Device Lot Number3030141
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/13/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/23/2023
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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