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

Model Number EVD35-07-150-150

Device Problem Material Deformation (2976)

Patient Problem Injury (2348)

Event Date 05/02/2020

Event Type  Injury  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician was attempting to use an everflex entrust se stent along with non medtronic 5fr sheath and 0.018 guide wire during procedure to treat a severely calcified lesion in the right proximal popliteal.The vessel is severely tortuous.The vessel diameter and lesion length are 7mm and 150mm respectively.There was no damage to device package.There were no issues while removing device from hoop/tray.The device was prepped per ifu with no issues identified.The lesion was predilated using a non medtronic pta balloon.The device passed through a previously deployed stent.There was no force used while advancing the device.It was reported that the right popliteal artery showed a in-stent restenosis.The vessel was prepped with a 4 x 60 non medtronic balloon.While deploying entrance everflex stent 7x150x150 the proximal end of the stent started to crumble for a short segment and then the remaining of the stent deploy normally.A 6 x 80 non medtronic balloon 035 was used to post dilate, followed by a 6 x 60 saber.018 non medtronic balloon.A 5x150 non medtronic cover stent was used to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Additional information: make and model of the previously deployed stent, in which in-stent restenosis was observed in the right popliteal is unknown.No resistance was felt upon delivering the device.The catheter handle was cracked open to deliver the remaining 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.

Manufacturer Narrative

Image review: four cine images were returned for review.It was observed that the target vessel location was located proximal to and at the patients knee joint, consistent with the reported target lesion.A guidewire was noted throughout all four cine images.The first cine image displayed an area of the patient¿s right leg, just proximal the knee joint.A deployed stent was noted; however due to the quality and clarity of the image, it was not possible to determine if the stent showed signs of elongation or compaction/foreshortening.The second cine image also contained an area just proximal the knee joint.Two deployed stents were noted in the cine; however, due to the quality and clarity of the image, compaction of stent rows could not be determined.The third cine image displayed the patient¿s right leg and contained the femur, medial condyle and lateral condyle of the femur, tibia, and the articular surface of the medial and lateral condyles.Three deployed, overlapping stents were observed in the cine.The distal stent appeared to span both sides of the knee joint.The stent was appeared to be a cover stent.Due to the quality and clarity of the cine, it was not possible to determine if any of the stent exhibited compaction or elongation of the stent cell rows.The fourth cine image contained the femur, medial condyle and lateral condyle of the femur, and the articular surface of the medial and lateral condyles.It was noted that a stent was deployed within the vessel.Abnormal deployment of the stent could not be identified in the image.No compaction or elongation of the stent cell rows was observed.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
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10032999
• MDR Text Key: 190309694
• Report Number: 2183870-2020-00140
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051719
• UDI-Public: 00821684051719
• Combination Product (y/n): N
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 06/23/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 02/09/2023
• Device Model Number: EVD35-07-150-150
• Device Catalogue Number: EVD35-07-150-150
• Device Lot Number: A973579
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/05/2020
• Initial Date FDA Received: 05/07/2020
• Supplement Dates Manufacturer Received: 05/15/2020; 06/22/2020
• Supplement Dates FDA Received: 05/19/2020; 06/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 84 YR
• Patient Weight: 81