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

Catalog Number EVD35-08-120-120

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/22/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician intended to use an everflex entrust to treat a 120mm moderately calcified lesion with 90% stenosis in the right proximal, mid and distal external iliac of diameter 7mm.A 6fr terumo sheath and an 0.035 guidewire was used.No embolic protection was used.The lesion was not pre-dilated.The device was prepped with no issues.The device did pass through a previously deployed stent.No resistance was encountered during advancement and no excessive force was used.It was reported that the stent seemed to push out from the distal mark rather than the outer sheath retracting over the catheter.The stent was deployed incorrectly and remains in the patient.No patient injury was reported.

Manufacturer Narrative

Image review: seven photographs of cine images were received for analysis.The images confirm deployment of the everflex stent in the abdominal aorta and in the right proximal iliac artery.The images confirm that a stent was previously implanted.Image one shows the entrust stent delivery system (sds) in the right iliac artery and approximately 10 stent cell rows in the abdominal aorta.The image clearly shows the previously implanted stent in the right iliac artery.The everflex stent is fully enclosed in the outer sheath of the sds.In image two the sds has been pulled back into the right iliac artery and out of the abdominal aorta.Image three shows the stent in deployment.A portion of the stent is being deployed in the abdominal aorta.The distal end of the outer sheath of the sds is in the abdominal aorta.Due to the quality and clarity of the image it is not possible to determine if the stent has reached vessel opposition within the abdominal aorta.The everflex stent appears to have reached its full expansion diameter.The distal end of the inner guidewire lumen/pusher is in contact with the proximal end of the enclosed stent; this indicates that the stent did not ¿jump¿ at the initiation of stent deployment.Image four is similar to image three but is of a darker contrast.The everflex stent is in deployment within the abdominal aorta and the distal end of the outer sheath of the sds is in the abdominal aorta.Due to the quality and clarity of the image it is not possible to determine if the stent has reached vessel opposition within the abdominal aorta.The everflex stent appears to have reached its full expansion diameter.The distal end of the inner guidewire lumen/pusher is in contact with the proximal end of the enclosed stent; this indicates that the stent did not ¿jump¿ at the initiation of stent deployment.Image five shows the deployment of the stent in the abdominal aorta and the right iliac artery.The stent cell diameter within the right iliac artery is less than stent cell diameter in the abdominal aorta; indicating that within the right iliac artery the stent has reached vessel opposition.Image six shows uneven expansion of the stent cell rows within the right iliac artery.Some of the stent cell rows show stent cell elongation; this is an indicator of deployment difficulty.It is noted that the distal end of the inner guidewire lumen/pusher is not in contact with the proximal end of the stent; this is an indicator that the delivery system is not being held in a fixed position during the deployment.Image seven shows the stent fully deployed and overlapping with the previously implanted stent.The section of the stent within the right iliac artery shows uneven expansion and stent cell elongation.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information 60% of the stent was deployed in target lesion, with the remaining 40% was deployed high into the abdominal aorta.No intervention was required.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: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8292228
• MDR Text Key: 134569409
• Report Number: 2183870-2019-00047
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051542
• UDI-Public: 00821684051542
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2019

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: 01/12/2021
• Device Catalogue Number: EVD35-08-120-120
• Device Lot Number: A581156
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2019
• Initial Date FDA Received: 01/31/2019
• Supplement Dates Manufacturer Received: 01/31/2019; 05/06/2019
• Supplement Dates FDA Received: 02/20/2019; 05/16/2019
• Date Device Manufactured: 01/13/2018
• 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): Other
• Patient Age: 73 YR
• Patient Weight: 113