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

Catalog Number EVD35-07-060-150

Device Problem Inaccurate Delivery (2339)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/18/2016

Event Type  malfunction  

Manufacturer Narrative

Device evaluation: the everflex entrust sds was received loose with in a plastic pouch.The entrust sds was returned without the red safety tab and locking tube.Several kinks in the catheter were noted.The kinks in the catheter may have formed post procedure given how the device was packaged for return.The entrust handle was examined.No red safety tubing was noted within the safety tab cavity.The silver colored outer sleeve was visible within the safety tab cavity.No pull cable was visible within the safety tab cavity.The entrust delivery catheter was examined.Kinks in the catheter were noted approximately at 56.7cm, 69.0cm, 72.0cm, 81.5cm, 85.0cm, 93.5cm, 96.4cm, 104.6cm, 108.2cm, 109.6cm, 136.4cm, and 148.7cm distal of the proximal hub luer lock.Approximately 18cm of the inner guidewire lumen is exposed.The entrust delivery catheter handle was examined.The printed strain relief was removed from the handle: it was noted that the adhesive bond between the blue outer isolation strain relief and the handle had separated.The separation may have happened post procedure given how the device was packaged for return.The handle was opened up.The silver colored outer is at its most proximal position under the cable pulley, the pull cable is still attached to the outer, and the pull cable is properly wound around the thumbwheel.The outer sheath is deformed where it is attached to the pull cable from the pull cable applying a vertical force as it goes over the pulley.Cine image review: cine image 1 is of a bifurcated vessel with a guidewire navigated through both branches of the vessel.Per the initial report, these are the proximal common iliac arteries.Cine image 2 is of the left proximal common iliac artery with a guidewire and an everflex stent within the outer sheath of the entrust stent delivery system.The distal marker bands of the stent are positioned at the ostium of the left proximal common iliac artery.Cine image 3 is of same vessel but the everflex stent has been deployed.The distal markers of the everflex stent are beyond the ostium of the left proximal common iliac artery.The distal markers appear to be in the abdominal aorta.Cine image 4 is of the same vessel after post dilatation of the everflex stent.The cines confirm that the everflex stent was implanted beyond the targeted vessel site.Cine images 5-8 are of the visi-pro procedure.

Event Description

Physician attempted to treat patient using an everflex entrust self-expanding stent and a visi-pro balloon expandable stent.Target lesion was the left proximal common iliac artery.Lesion had no tortuosity, severe calcification and total chronic occlusion.Artery diameter was 8 mm and lesion length was 30-40 mm.Lesion was pre-dilated using 4, 5, 6, 7, and 8, 40/80 everflex balloons.It is reported that no resistance was encountered when advancing the everflex entrust stent to the lesion.Lock-pin had been checked for securement prior to procedure and was removed after correctly positioning at the lesion.It is reported that stent jumped into aorta after pulling the stent past the lesion to release tension.The everflex entrust stent was to be placed just prior to bifurcation of aorta in the left common iliac.The physician took distal angio runoffs with no impediment of flow to right lower extremity despite stent jumping into aorta.However, the physician stated the patient will still need bypass due to cto in left iliac due to patient history despite stent placements.Resistance was encountered when advancing the visi-pro stent.It was reported that the visi-pro stent did not deploy in correct vessel.Balloon was inflated in left common iliac with no visualization of stent upon dilation and deflation of balloon.The physician then pulled out visi-pro with no stent visualization mounted on balloon upon inspection.Stent was then visualized in left external iliac/common femoral artery.It is reported that balloon was inflated in left common iliac with no visualization of stent upon dilation and deflation of balloon.It is reported both stents were fully apposed to artery wall.No additional stent used to cover target lesion.Physician stated patient will still need bypass due to cto in left iliac due to patient history despite stent placements.Patient is reported to be stable.The physician reported patient still had flow to sfa on last angio during procedure.

Manufacturer Narrative

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
• 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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 6108797
• MDR Text Key: 60089445
• Report Number: 2183870-2016-00669
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/01/2016

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
• Device Operator: Health Professional
• Device Expiration Date: 07/07/2019
• Device Catalogue Number: EVD35-07-060-150
• Device Lot Number: A306131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2016
• Initial Date FDA Received: 11/17/2016
• Supplement Dates Manufacturer Received: Not provided; 11/01/2016
• Supplement Dates FDA Received: 01/11/2017; 09/27/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2016
• 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 Age: 60 YR
• Patient Weight: 60