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 Problems Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/10/2017

Event Type  malfunction  

Event Description

Physician intended to use an everflex self-expanding stent with entrust delivery system with a 6f sheath and a non-medtronic guidewire for the treatment of a severely calcified lesion in the distal superficial femoral artery (sfa) which exhibited >90% stenosis.Embolic protection was not used.There was no damage noted to packaging.Ifu was followed and the device was prepped without issue.It was reported that physician experienced some resistance when advancing the device.It was reported that stent dislodgement occurred during deployment.The dislodged stent was removed but fragments were left and wire removed.There was no damage to the deployment mechanism or device handle prior to deployment and it is reported the lock-pin was removed prior to deployment.The device did not pass through a previously deployed stent.Physician used a balloon expandable stent in the lesion area.No patient injury reported.

Manufacturer Narrative

Device evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation.The entrust sds was received loaded on a 0.035¿ compatible guidewire.A portion of the stent was exposed.The distal end of the exposed stent did not have any of the stent radiopaque marker hoops.The distal end of the exposed stent exhibited tearing of the stent struts.The proximal end of the stent was located using back lighting.Approximately 7mm of the 150mm stent were not returned with the entrust stent deployment system.The blue isolation sheath was moved distally exposing the inner guidewire lumen/pusher.Dried sanguine residue was noted along the length of the freshly exposed inner guidewire lumen/pusher.It was noted that the outer sheath was moving along with the isolation sheath.It was also noted that the guidewire was able to be removed from the proximal hub luer lock with ease after the isolation sheath and outer sheath were moved distally.The blue strain relief/isolation sheath was skived off the gold isolation sheath until the blue strain relief could be advanced proximally off the gold isolation sheath and silver outer sheath.It was noted that the pull cable was still attached to the outer sheath.It was also noted that the gold isolation sheath and silver outer sheath could not move independent of each other.Dry sanguine residue was note on the exterior of the exposed silver outer sheath.Back lighting was used to locate the distal end of the inner guidewire lumen/pusher.The distal end of the inner guidewire lumen/pusher was located approximately 131cm from the distal end of the proximal hub.The catheter section of entrust stent delivery system was allowed to soak over 72 hours to re-hydrate the dry sanguine residue in order to flush it from the delivery system.The guidewire returned was re-loaded into the entrust stent delivery system.The guidewire returned with the device exhibits drag witness marks from where it interacted with the stent.Stands of skived ribbons from the returned guidewire are visible on the stent struts.A mass of skived ribbons from the returned guidewire was noted on the guidewire.The stent was able to be deployed after rehydration of the sanguine residue by pinning the guidewire loaded inner and manually pulling the outer sheath.At the distal end of the inner guidewire lumen/pusher was a mass of sanguine residue.Transparent strands of polymer were observed on the exterior of the inner guidewire lumen/pusher.Approximately 143mm of the stent of the 150mm were returned.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: 6853497
• MDR Text Key: 85761978
• Report Number: 2183870-2017-00386
• 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: 11/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/06/2019
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A305401
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/06/2016
• 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