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

Catalog Number EVX35-06-150-120

Device Problems Difficult to Remove (1528); Physical Resistance/Sticking (4012)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The physician used an everflex entrust with a non-medtronic 6fr sheath and a non-medtronic 0.035" guidewire to treat a 260mm calcified/plaque lesion in the patients proximal right superficial femoral artery (sfa) of diameter 6mm.The lesion exhibited 70-80% stenosis.Moderate calcification and tortuousity were reported.The ifu was followed and the device prepped without issue.Pre-dilation of the entire sfa was carried out using a non-medtronic pta balloon.An everflex entrust self-expanding stent, which was prepped with no issues noted, was deployed successfully in the mid sfa.Following this the physician wanted to deploy a second overlapping everflex entrust in the proximal sfa but during advancement of the device over the non-medtronic guidewire, it was met with resistance and was unable to cross the lesion.The physician made a few attempts to advance the everflex entrust unsuccessfully.When the physician attempted to remove the device, difficulty was experienced.The everflex entrust had to be removed with the non-medtronic guidewire as a whole.A new non-medtronic guidewire was opened and the procedure was completed by deployment of a non-medtronic self-expanding stent.No patient injury reported.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: the everflex entrust stent delivery system was received for evaluation.No cine images were received for evaluation.The entrust sds was received loaded on a 0.035¿ compatible guidewire.Push and pull forces were applied to the proximal end of the guidewire: no advancement in either direction was achieved.Push and pull forces were applied to the distal end of the guidewire: no advancement in either direction was achieved.The entrust sds was locked up on the guidewire.The entrust sds was received with the red safety tab still engaged with the sds handle.The distal tip of the outer sheath was examined.Distal radiopaque marker hoops of the stent could be seen in the clear section of the distal tip.The distal end of the isolation sheath was approximately 54.4cm proximal of the distal tip of the sds outer sheath.A separation of the isolation sheath was noted approximately 83.5cm proximal of the distal tip of the sds outer sheath.The guidewire proximal to the proximal hub of the entrust sds handle exhibited areas of where the guidewire coating/jacket was bunched up and the guidewire core wire was exposed.The coating/jacket of the guidewire had slid proximal over its proximal end.From approximately 64.8cm to 70.5cm from the proximal end of the guidewire, the guidewire coating/jacket exhibited damage.From approximately 75.0cm to 86.2cm the guidewire coating/jacket had separated exposing the guidewire core wire.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: 7694109
• MDR Text Key: 114685030
• Report Number: 2183870-2018-00383
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: SN
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 10/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2019
• Device Catalogue Number: EVX35-06-150-120
• Device Lot Number: A368329
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2016
• 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