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

Catalog Number	EVD35-08-040-080
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/18/2019
Type of Reportable Event	Malfunction
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 with a 6fr x 55cm sheath and 0.018 guidewire during treatment of a 30mm calcified lesion in the patient¿s common iliac artery of diameter 8mm.Moderate tortuosity and severe calcification are reported.The lesion exhibited 60% stenosis.Ifu was followed and the device was prepped without issue.No resistance was encountered when advancing the device.It is reported that stent deformation occurred in vivo during positioning/deployment.The stent was deployed.It is reported the deployment issue led to the stent bunching up in the external iliac.The physician post-dilated with a 8x40mm evercross balloon.Possibly the post dilatation balloon might have caught on and moved the stent but this is not confirmed.No patient injury reported.
Additional Manufacturer Narrative
Additional information: the stent was deployed in the target area.Due to stent shortening observed, stent measured 20mm in the vessel.No resistance was en countered when removing the delivery system from the patient.No additional treatment has been required.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.
Additional Manufacturer Narrative
Image review: five photographic images of cine images were received.The first image is of the targeted vessel.A radiopaque marker band of a sheath is visible at the top of the cine with a guidewire running through the common iliac artery.The second image is a close-up of the targeted lesion.A radiopaque marker band of a sheath is visible at the top of the cine with a guidewire running through the lesion in the common iliac artery.The third image is of the deployed everflex stent.Due to the quality and clarity of the image it is not possible to identify individual strut rows or positively determine the orientation of the stent struts.When compared to the vessel diameter the length of the stent appears to be about three vessel diameters.The stent appears to be in a bend in the external iliac and the vessel may not totally lie in the focal plane of the cine.The combination of the bend in the vessel and the vessel not totally lying in the focal plane of the cine may contribute to optical parallax that results in the stent to appear to be shortened.Image four is of a non-inflated balloon catheter on the guidewire within the stent at the targeted vessel anatomy.It is not known if the image was taken before or after inflation of the evercross balloon.Image five is a post-treatment contrast flow image.The targeted vessel anatomy appears to be re-opened.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.
Additional Manufacturer Narrative
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 STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8726794
• Report Number: 2183870-2019-00344
• Device Sequence Number: 1729066
• Product Code: NIP
• UDI-Device Identifier: 00821684051276
• UDI-Public: 00821684051276
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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,Followup
• Report Date (Section B): 09/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/04/2022
• Device Catalogue Number: EVD35-08-040-080
• Device Lot Number: A778159
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 08/13/2019; 08/29/2019; 09/17/2019
• Initial Report FDA Received Date: 06/24/2019
• Supplement Report FDA Received Date: 08/14/2019; 08/30/2019; 09/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Weight: 68