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 Fracture (1260); Material Deformation (2976)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician attempted to use an everflex entrust with a non-medtronic 5fr sheath and a non-medtronic 0.014 guidewire for the treatment of the right distal popliteal artery.Lesion length and artery diameter were respectively 120mm and 5mm.The device was prepped as per the ifu with no issues identified.The device did not cross a previously-deployed stent and no resistance was encountered when advancing the device.Lesion was pre-dilated with a 4mm x 100mm balloon.The thumbscrew/lock-pin was checked for securement prior to procedure and it was removed before deployment.It was reported that stent deformation followed by fracture occurred upon stent deployment into patient¿s vessel.The physician advanced the stent and when deploying, he noticed a grinding and then the stent fractured.The deployment system was removed; however, part of the stent became lodged at access site, partially in the artery and partially in the subcutaneous tissue.Approximately 40mm of the stent remained in the target vessel and the other fractured portion was located in the common femoral artery.Surgery was required to remove the fragments.

Manufacturer Narrative

Device evaluation: the everflex entrust stent delivery system, (sds), was received for evaluation within a sealed tyvek pouch, and loosely coiled within a nested series of sealed plastic biohazard pouches along with a stent fragment.No cines from the procedure were received for evaluation.The entrust sds was received locked up on a 0.014¿ compatible guidewire.An approximate 60mm portion of the stent was returned with an unidentified fibre tangled within the stent strut cells.The entrust sds handle was examined; a bent portion of the inner guidewire lumen was observed kinked and protruding from the handle¿s safety tab cavity.The kinking of the inner guidewire lumen most likely happened during deployment attempt and was caused by the guidewire lumen being not fully supported by the 0.014¿ compatible guidewire.The distal end of the sds outer sheath was examined using back lighting; no stent or stent segment was located in the outer sheath.The entrust catheter assembly was examined.A set of kinks were noted in the outer sheath approximately 49.2cm and 52.8cm from the distal end of the outer sheath.The proximal end of the outer sheath was located approximately 121.7cm from the distal end of the outer sheath.It appears that the pull cable bond to the outer sheath was broken at the bond.The inner guidewire lumen is exposed from 121.7cm to 135.2cm.The exposed inner guidewire lumen and exposed proximal end of the outer sheath indicate that the outer sheath was held by a force during withdrawal of the entrust stent delivery system.The distal end of the gold colored isolation sheath is approximately 135.2 cm from the distal end of the outer sheath.The distal end of the blue isolation sheath is approximately 192.8cm from the distal end of the outer sheath.A kink in the gold coloured isolation sheath was noted at the distal end of the blue isolation sheath.The printed strain relief was removed from the entrust stent deployment system handle to allow for further examination of the system.A kink in the inner guidewire lumen was noted just distal of the distal end of the handle.The kink in the inner guidewire lumen most likely happened due to the guidewire lumen being not fully supported by the 0.014¿ guidewire.The entrust stent deployment system handle was split opened.The pull cable is wound around the thumbwheel.The distal tip of the handle assembly was examined for unusual wear/witness marks: none were found this indicates that the pull cable was properly routed within the handle assembly.The inner guidewire lumen is kinked up within the handle¿s safety tab cavity.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Lesion was a calcified cto (chronic total occlusion).Difficulty experienced during withdrawal.Surgery was required to remove the fragment from the patient¿s common femoral artery.Fragment detached at lesion site remains.No occlusion to patient¿s vasculature reported.No further stenting was carried out.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: 8281913
• MDR Text Key: 134228373
• Report Number: 2183870-2019-00039
• 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,Followup
• Report Date: 04/24/2019

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: 10/23/2021
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A729102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 01/28/2019
• Supplement Dates Manufacturer Received: 02/04/2019; 04/19/2019
• Supplement Dates FDA Received: 02/21/2019; 04/24/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/24/2018
• 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): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 77