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

Catalog Number EVX35-08-080-150

Device Problem Malposition of Device (2616)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 05/20/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use an everflex entrust stent to treat a plaque slightly calcified, moderately tortuous chronic total occlusion (cto, 100%) lesion in the proximal left common iliac artery.The lesion was pre-dilated with an 8x40 evercross device.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped without issue.A 6fr sheath and a 0.35 guidewire were used with no embolic protection device for the procedure.There was no resistance encountered nor excessive force applied during delivery of the device to the lesion.It was reported that the stent dislodged into the patient¿s aorta.The physician left the stent in the aorta and completed the procedure with an 8x54 visipro balloon expandable stent.There was no patient injury reported.

Manufacturer Narrative

It was reported the physician was attempting to deploy the stent at the iliac ostium, the stent jumped into as soon as it deployed and dislodged into the patient¿s aorta.The physician left the stent in the aorta and successfully completed the procedure with a visipro balloon.No further intervention reported.There patient was discharged.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the everflex entrust was returned.No ancillary devices were included.It was noted the outer catheter protector was loaded over the catheter shaft with the red pull cable remained inserted the handle assembly.The locking pin was not loosely inserted the handle assembly and it was noted the locking tub was visible between the halves of the handle assembly.It was discovered the inner assembly was outside of the distal rim of the outer assembly by approximately 10 cm.No bends or external damages were noted to the catheter shaft or inner assembly.The working length of the deployment system in the condition the unit was returned was approximately 137cm.It should be noted the product labelling associated to lot a548373 indicates a working length of 150cm.The red locking tube was visible approximately 7cm from the locking pin.Under microscope it was observed the locking tube was bent downward and proximally the handle assembly was cracked open and observed the locking tube was folded proximally and the distal end of the locking tube remain ed within the proximal end of the silver outer.The segment of the locking tubing that was bent proximally showed stretching/stress to the lock tubing.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: 8643958
• MDR Text Key: 146219394
• Report Number: 2183870-2019-00309
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/20/2019

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: 10/30/2020
• Device Catalogue Number: EVX35-08-080-150
• Device Lot Number: A548373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/21/2019
• Initial Date FDA Received: 05/27/2019
• Supplement Dates Manufacturer Received: 06/10/2019; 08/19/2019
• Supplement Dates FDA Received: 07/01/2019; 08/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/31/2017
• 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
• Patient Age: 56 YR
• Patient Weight: 90