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

Catalog Number	EVD35-08-080-080
Medical Device Problem Codes	Fracture (1260); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Physician attempted to use an everflex entrust self-expanding stent with a 7fr 23cm non-medtronic sheath and a 180cm.035 non-medtronic guidewire during treatment of a 60mm plaque lesion in the patient¿s left distal common iliac artery.Minimal vessel tortuosity was reported.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.The ifu (instruction for use) was followed during preparation, procedure, post-procedure without issue.Embolic protection was not used.The vessel was not pre-dilated.The vessel was post-dilated.The device was passed through a previously deployed visipro 8x17 stent.No resistance was encountered when advancing the device.Patient had prior kissing iliac stents but a reasonably good bifurcation.Access was made up-and-over from right gro in to left side and a stent was needed distal to the existing left common iliac stent down into the left external iliac.An 8x80 everflex entrust was selected.The entrust was loaded on the wire and advanced to the target location.The thumbscrew/lock-pin was checked for securement prior to procedure.The thumbscrew/lock-pin was removed prior to attempted deployment.The red pull tab was removed and noted to be fully intact.The physician used the thumb wheel to deploy the stent.Deployment issues were reported.It was reported that the stent partially deployed at the target site within the patient vasculature.Initially it went smoothly but physician reached increasing difficulty in the thumb wheel¿s rotation about halfway through deployment.It was thought that the angle of the bifurcation was creating a crimp in the deployment mechanism, so the physician attempted to remove the non-medtronic guidewire but found that it would not come out of the entrust catheter.The medtronic sales rep, instructed physician to break the handle according to ifu.We did so without any issues.The physician held the gold sheath and pulled on the string.This required considerable effort but the stent did appear to deploy.As physician removed the entrust system off the wire, it was noted the proximal end of the stent had fractured and remained partially locked in the gold sheath.The stent remains in the patient.There were no attempts to rem ove the stent.The stent was deployed in the target lesion.Angiography revealed an under-expanded stent with no visible proximal marker bands.Access was gained in the ipsilateral right groin and a wire was snaked through the fractured stent into the aorta.A catheter was advanced into the aorta to verify the wire had not gone through a strut.Angiography through the catheter could not demarcate where exactly the proximal end of the stent was.A 6x40mm non-medtronic balloon was used to serially dilate the stent.Then, a 7x37x80 visi-pro stent was advanced into the everflex stent and was used to re-line the fractured proximal end with post-dilation to 8mm.The end angiographic result was excellent.The delivery system was safely removed from the patient.No vessel damage was reported.No patient injury reported.
Additional Manufacturer Narrative
Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Product analysis: the device returned with the handle opened and the red locking pin was removed from the device.There was no damage observed to the red locking pin.The stent struts were broken.The size indicated on the strain relief was 8 x 80mm.The handle was open on the returned device.The wire was attached to the gold sheath.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM STANDARD
• Common Device Name: 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: 20264847
• Report Number: 2183870-2024-00306
• Device Sequence Number: 8298668
• Product Code: NIP
• UDI-Device Identifier: 00821684051290
• UDI-Public: 00821684051290
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/01/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/26/2026
• Device Catalogue Number: EVD35-08-080-080
• Device Lot Number: B601696
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2024
• Supplement Date Received by Manufacturer: 11/25/2024
• Initial Report FDA Received Date: 09/20/2024
• Supplement Report FDA Received Date: 12/01/2024
• Date Device Manufactured: 07/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 71 YR
• Patient Sex: Female