MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number	EVD35-08-150-120
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/19/2019
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
Physician used an everflex entrust self-expanding stent system with a non-medtronic 5f sheath and 0.014 guidewire during treatment of a 150mm, calcified cto (chronic total occlusion-100%) in the patient¿s proximal right superficial femoral artery (sfa) of diameter 8mm.Severe vessel calcification and moderate tortuosity are reported.Embolic protection was not used.Ifu was followed.No damage noted to packaging prior to use.No issues noted when removing device from packaging.Device prepped without issue.Access as via the right popliteal artery with the 5f sheath.Angiogram of the right sfa and common femoral artery were taken.Angiogram showed cto of right common femoral and sfa.The everflex entrust stent was deployed through the right common femoral and sfa.After stent deployment a crumble mid-section of stent was noticed.A non-medtronic balloon was used in the right common femoral and sfa to post dilate.The stent still appeared deformed, so a non-medtronic stent was deployed inside the deformed entrust everflex stent.No adverse event reported for the patient.
Additional Manufacturer Narrative
Additional information: the patient is alive and without injuries.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cine image review: preliminary evaluation of the provided 9 cine images show more than one stent implanted within the same vessel.The images provided show four separate condensed area of tantalum markers within a single vessel, indicating two separate stents implanted.An evaluation of the stents showed no clear signs of damage or fracturing.The clarity provided cine images were unable to conclusively identify the area of the reported "crumble" of the stent.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9353221
• Report Number: 2183870-2019-00549
• Device Sequence Number: 2237680
• Product Code: NIP
• UDI-Device Identifier: 00821684051559
• UDI-Public: 00821684051559
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/04/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/21/2022
• Device Model Number: EVD35-08-150-120
• Device Catalogue Number: EVD35-08-150-120
• Device Lot Number: A886930
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 11/28/2019; 02/03/2020
• Initial Report FDA Received Date: 11/21/2019
• Supplement Report FDA Received Date: 12/02/2019; 02/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 68 YR
• Patient Weight: 91