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

Catalog Number EVD35-06-150-120

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problems Hematoma (1884); Injury (2348)

Event Date 09/04/2019

Event Type  Injury  

Manufacturer Narrative

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.

Event Description

Physician was attempted to use an everflex entrust self-expanding stent to treat a lesion in the mid sfa.There was no damage noted to packaging.No issues noted when removing the device from the hoop/tray.The device was prepped per ifu with no issues identified.The device did not pass through a previously deployed stent.The thumbscrew/lock-pin was checked for securement prior to procedure.The lock-pin was deployed before deployment.It was reported that device was unable to be deployed, but when device was removed it was partially deployed.Patient symptoms or complications associated with this event is vessel damage/injury and hematoma.

Manufacturer Narrative

Device evaluation the entrust sds was received with a segment of the everflex stent exposed and flowered.The distal radiopaque hoop markers of the stent were not present indicating that the stent was under tensile forces that cause the stent to fracture.The handle¿s safety locking tab cavity was examined: the inner guidewire lumen did not exhibit any kinking or accordion folding.The pull cable could not be observed in the cavity indicating that the pull cable either broke or the pull cable to outer sheath bond broke.The catheter portion of the sds was examined the isolation sheath ended approximately 70.2cm distal of the printed strain relief distal tip.The inner guidewire lumen was exposed from 70.2cm to 109.3cm distal of the printed strain relief distal tip.Approximately 39.1cm of the inner guidewire lumen was exposed.The proximal end of the silver colored outer sheath was located approximately 109.3cm distal of the printed strain relief distal tip.The sds outer sheath distal tip was intact with approximately 1 stent row of struts exposed and flowered.Backlighting of the distal end of sds catheter outer sheath was conducted to locate the proximal end of the stent.Approximately 13.2cm of the 150mm length stent remain within the distal end of the outer sheath.Backlighting of the outer sheath was conducted to locate the distal end of the inner guidewire lumen/pusher.The distal end of the inner guidewire lumen/pusher was located approximately 116.5cm from the distal end of outer sheath and approximately 5.8cm from the proximal end of the outer sheath.The distal end of the inner guidewire lumen is approximately 103.3cm from the proximal end of the stent within the outer sheath of the sds.During the backlight of the outer sheath several zones of lateral compression of the outer sheath were located.The zones of lateral compression are located approximately 27.5cm, 4135cm, 73.5cm, and 101.1cm from the distal end of the outer sheath.It is not known when the zones of lateral compression were formed.They may have formed post-procedure given how the device was packaged for return.The distal end of the outer sheath exhibits tensile damage.The pull cable appears to have been pulled out of its weave in the outer sheath.The printed strain relief on the sds was removed to allow further examination of the handle.The no unusual wear patterns were noted in/on the interior of the handle; indicating that the pull cable had been properly routed.The proximal hub was cut off from the inner guidewire lumen to allow further examination of the sds catheter components.The isolation sheath and inner guidewire lumen was able to be removed from the outer sheath with ease.Tensile forces were applied to the proximal end of the inner guidewire lumen and the inner guidewire lumen could not be removed from the isolation sheath.Sanguine colored dried residue was noted within the isolation sheath and appears to be a contributing factor in the inability to remove the inner guidewire lumen from the isolation sheath.The exposed stent segment was gently held between thumb and forefinger while a light tensile force was applied to the outer sheath allowed the stent to be removed from the outer sheath.A strand of sanguine colored coagulated thrombus material was noted within the stent and between the stent and outer sheath.The strand of material was water soluble.The distal end of the outer sheath was skived opened and examined: no witness marks of stent and liner interaction were noted.The liner did not exhibit any signs of delamination.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: 8979353
• MDR Text Key: 159518797
• Report Number: 2183870-2019-00437
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051399
• UDI-Public: 00821684051399
• 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
• Report Date: 01/17/2020

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: 04/22/2022
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A819913
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/10/2019
• Supplement Dates Manufacturer Received: 01/16/2020
• Supplement Dates FDA Received: 01/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/23/2019
• 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