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U.S. Department of Health and Human Services

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

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ABBOTT VASCULAR XIENCE EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT DELIVERY SYSTEM Back to Search Results
Catalog Number UNK XIENCE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Ischemia (1942); Myocardial Infarction (1969); Thrombosis (2100)
Event Date 09/08/2020
Event Type  Death  
Manufacturer Narrative
Estimated date of death. Estimated date of event. The udi is unknown because the part number and lot number were not provided. Estimated date of implant. The device was not returned for evaluation. The reported patient effect of death is listed in the xience v and xience nano everolimus eluting coronary stent systems instructions for use as a known patient effect of coronary procedures. A review of the lot history record of the reported lot could not be conducted because the part and lot number were not provided. A conclusive cause for the reported death and the relationship to the product, if any, cannot be determined. There is no indication of a product quality issue with respect to manufacture, design or labeling. The adverse patient effects mentioned are being filed in a separate medwatch report number. Article: comparison of ultrathin, bioresorbable-polymer sirolimus-eluting stents and thin, durable- polymer everolimus-eluting stents in calcified or small vessel lesions.
 
Event Description
It was reported through a research article identifying that xience stents may be related to the following: death, myocardial infarction, ischemia, stent-thrombosis, rehospitalization and revascularization. This article summarizes clinical outcomes of 784 patients that were treated with xience stents. Specific patient information is documented as unknown. Details are listed in the article, titled "comparison of ultrathin, bioresorbable-polymer sirolimus-eluting stents and thin, durable- polymer everolimus-eluting stents in calcified or small vessel lesions. ".
 
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Brand NameXIENCE 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 Key11343283
MDR Text Key232376793
Report Number2024168-2021-01288
Device Sequence Number1
Product Code NIQ
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
P070015
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 02/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/18/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNK 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 Received02/10/2021
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/18/2021 Patient Sequence Number: 1
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