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

Catalog Number EVD35-06-150-150

Device Problems Difficult to Remove (1528); Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Material Deformation (2976)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 05/24/2022

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 self-expanding stent during procedure to treat a none calcified lesion in the proximal, mid and distal superficial femoral artery (sfa) with chronic total occlusion (cto-100%).The vessel was none tortuous.There was no damage noted to packaging.There was no issue noted when removing device from hoop/tray.Stent deformation occurred in vivo during positioning/deployment.The length of deployed stent in vessel is 150mm.Removal difficulties occurred with difficulty removing device following stent deployment.In accurate delivery was reported (i.E.Stent deployed in unintended lesion site).There was sufficient distal landing zone with partial deployment reported.The thumbscrew/lock-pin checked for securement prior to procedure.The lesion was not pre dilated.The device did not pass through a previously deployed stent.It was reported that the entrust stent had to be taken apart to be deployed as a pin and pull stent because the stent would no longer deploy by the thumb wheel , the phys ician then had great difficulty removing the catheter and in this, the stent stretched longer than 150mm.

Manufacturer Narrative

Additional information: the patient had infected wound 1st toe right foot with osteomyelitis secondary to severe chronic limb ischemia with evidence of arterial occlusive disease both lower extremities on noninvasive vascular studies.The patient was positioned supine and the groins and left upper extremity were prepped and draped in the usual sterile fashion.Cons cious sedation, local anesthesia.The left brachial artery was access in the upper 3rd of the upper arm under ultrasound guidance using a micropuncture kit which was then upgraded to a 6 french sheath.Permanent record of ultrasound imaging was obtained.Using a vertebral catheter and a glidewire access was gained to the descending aorta and catheter and wire were advanced to the abdominal aorta.A j-wire was then inserted and then the catheter was exchanged for a pigtail catheter and abdominal aortogram was obtained and then a bilateral lower extremity runoff angiogram was obtained.The aorta had diffuse atherosclerotic changes but no hemodynamically significant stenosis.On the left side was a total occlusion of the proximal common iliac artery with faint reconstitution of the proximal superficial femoral artery and very minimal flow to the left lower extremity.On the right side there was a hemodynamically significant stenosis of the common iliac artery a 60% stenosis the common femoral artery.The profunda femoral artery was patent and the superficial femoral artery was totally occluded at the origin with reconstitution of the suprageniculate popliteal artery via profunda collaterals.The popliteal artery was patent what appeared to be a three-vessel runoff.A non-medtronic wire was then inserted and the pigtail catheter removed along with the sheath and replaced by a 7 french 90cm non-medtronic sheath which was advanced and positioned in the distal common iliac artery proximal external iliac artery on the right side.Using a non-medtronic wire and a non-medtronic catheter access was gained to the superficial femoral artery and catheter and wire were advanced down the superficial femoral artery.The wire was then replaced by a 18 non-medtronic wire and a 018 non-medtronic catheter 150cm long and this catheter wire combination was advanced traversing the total occlusion all the way to the popliteal artery.Contrast injection through the catheter confirmed the correct placement within the lumen of the patent popliteal artery.A 014 wire was then placed and the catheter was removed.Percutaneous transluminal angioplasty of the superficial femoral artery was performed starting with a 4mm balloon.Contrast injection showed evidence significant residual irregularities of the lumen and therefore a 150mm self expandable ev3 stent was advanced and positioned in the popliteal artery extended proximally and deployed.A 2nd 100mm ev3 stent was advanced overlapped into the existing wound and deployed.A 3rd ev3 stent was positioned proximal to with a 2cm overlap and position with the proximal end superficial femoral artery and deployment was started.Half way through the deployment of the stent the deployment system failed and broke.Following the instructions of the manufacture removed that the placement handle and complete the deployment of the stent by pin and pull technique.Unfortunately the stent stretched significantly and the proximal end of the stent and up into the common femoral artery.Using an 018 wire the wire was directed into the profunda femoral artery and balloon dilatation of the profunda was preformed stretching the struts of the stent to prevent jailing of the origin of the profunda.Attention was then turned to the superficial femoral artery again and the superficial femoral artery was realigned and the area of the mild deployed the ev3 stent using a non-medtronic self expandable stent and then a non-medtronic balloon expandable stent which was deployed all the way up to the origin of the superficial femoral artery.Balloon dilatation of the common femoral artery was then performed using a drug-eluting balloon and contrast injection though showed some thrombus within the common femoral artery origin of the profunda and origin of the superficial femoral artery.Therefore and the cuts catheter was placed extending from the popliteal on to the common femoral artery and the patient undergo ultrasound enhanced thrombolysis.Disposition plan after pacu: intensive care unit/surgical care unit 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

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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14571626
• MDR Text Key: 293446592
• Report Number: 2183870-2022-00193
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/02/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EVD35-06-150-150
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/05/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention