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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE V EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number 1009529-28
Device Problems Material Separation (1562); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/25/2021
Event Type  malfunction  
Event Description
It was reported that the procedure was to treat a heavily calcified, heavily tortuous, de novo lesion in the left anterior descending (lad) artery. A 3x28mm xience v drug eluting stent system (dess) was advanced, but difficulty was noted to reach the lesion, so force was applied and the shaft of the device separated outside of the anatomy into two pieces. The separated dess was simply removed. Two other xience v dess were attempted, but both failed to reach the lesion. The procedure was aborted, and the patient will be kept on medical management for treatment. There was no adverse patient effect and no clinically significant delay in the procedure. No additional information was provided.
 
Manufacturer Narrative
(b)(4). 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.
 
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Brand NameXIENCE V 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 Key12830133
MDR Text Key280941226
Report Number2024168-2021-10490
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeIN
PMA/PMN Number
P070015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative,Distributor
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/21/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number1009529-28
Device Lot Number1042941
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/16/2022
Is the Reporter a Health Professional? Yes
Date Manufacturer Received02/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/05/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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