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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY
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COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY Back to Search Results
Catalog Number EVD35-06-040-120
Medical Device Problem Code Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes Bacterial Infection (1735); Cellulitis (1768); Chest Pain (1776); Unspecified Infection (1930); Patient Problem/Medical Problem (2688)
Date of Event 12/30/2016
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
 
Event or Problem Description
It was reported that the patient had an everflex entrust stent implanted on (b)(6) 2016.Patient also had a competitor¿s stent implanted on (b)(6) 2017.Since then, the patient has had an array of symptoms such as cellulitis, bone infections, intermittent chest pain, 2 toes amputated and a staph infection of her toes.
 
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Brand Name
EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
Common Device Name
STENT, SUPERFICIAL FEMORAL ARTERY
Manufacturer (Section D)
COVIDIEN
4600 nathan lane north
plymouth MN 55442
MDR Report Key8766978
Report Number2183870-2019-00361
Device Sequence Number2043698
Product Code NIP
UDI-Device Identifier00821684051344
UDI-Public00821684051344
Combination Product (Y/N)N
PMA/510(K) Number
P110023
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2016
Reporter Type Manufacturer
Report Source other
Initial Reporter Occupation Other
Type of Report Initial
Report Date (Section B) 07/08/2019
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? No
Operator of Device Health Professional
Device Expiration Date07/21/2019
Device Catalogue NumberEVD35-06-040-120
Device Lot NumberA314036
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 07/03/2019
Initial Report FDA Received Date07/08/2019
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Disability;
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