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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 UNK RX XIENCE
Device Problem Patient-Device Incompatibility (2682)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/01/2011
Event Type  malfunction  
Manufacturer Narrative
Event estimated dates. The device was not returned as the stent remains in the patient. Investigation is not yet complete. A follow-up report will be submitted with all additional relevant information. The patient effects of death and serious injury referenced are being filed under separate medwatch reports. Literature attachment, title: long-term clinical outcomes of late stent malapposition detected by optical coherence tomography after drug-eluting stent implantation.
 
Event Description
It was reported through a research article identifying xience v stents that may be related to death, serious injury, and stent malapposition. Specific patient information is documented as unknown. Details are listed in the attached article, titled, long-term clinical outcomes of late stent malapposition detected by optical coherence tomography after drug-eluting stent implantation.
 
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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 Key9833105
MDR Text Key183481819
Report Number2024168-2020-02438
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeKS
PMA/PMN Number
P070015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/23/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK RX XIENCE
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 Received07/20/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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