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

Catalog Number EVX35-06-150-150

Device Problem Premature Activation (1484)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 02/15/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was attempting to use an everflex entrust self-expanding stent with a non-medtronic 6fr (terump ) sheath and 0.035x300cm non-medtronic (terumo) guidewire to treat a lesion in the sfa reported to be severely calcified, with moderate tortuosity in a patient.No issues noted to packaging, no issues noted when removing the device from hoop/tray.Device was prepped as per ifu.Embolic protection was not used.It was reported that the stent failed to deploy (failed to unfold); the stent had the first millimetre released, then no more.Entire system had to be recovered operationally.The lesion was not pre-dilated, the stent did not pass through a previously deployed stent, no resistance was encountered during advancement and no excessive force was used.No patient injury reported for this event.

Manufacturer Narrative

Device evaluation: the everflex entrust stent delivery system, (sds), was received for evaluation within a sealed plastic biohazard pouch, its transportation tray, and tube.No cines from the procedure were received for evaluation.Portions of a 0.035¿ guidewire were received with the device.The entrust sds was received with the red safety tab removed and a portion of the guidewire lumen sticking out of the red safety tab cavity in the handle.The pull cable was protruding out from the handle near the thumb wheel.The printed strain relief was removed and slid distally from the handle to allow further examination of the deployment handle.The handle was split open, the pull cable remained attached to the thumbwheel, and handle sections did not show wear from an improperly routed pull cable.The distal end of the outer sheath was found to have been cut into approximately 18.7cm segment.A set of kinks were located in the segment, approximately 4cm and 6.5cm from the distal tip of the outer sheath.The distal end of the outer sheath was examined, and no stent or stent segment was found within.A segment of the catheter was received remaining in the transportation tube.The segment was removed by pushing the segment with a pair of 0.035¿ guidewires out of the transportation tube.The segment included guidewire, inner guidewire lumen/pusher, outer sheath, and isolation sheath.The overall length of the segment was approximately 63.9cm.The distal segment of the inner guidewire lumen and guidewire were examined.A zone of lateral compression was noted in the inner guidewire lumen.With force the inner guidewire lumen was removed from the guidewire.The zone of lateral compression in the inner guidewire lumen aligns with a flat spot in the guidewire.The source of the lateral compression and flat spot in the distal segment could not be positively determined.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: device removed surgically.Bypass was performed.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: 8357386
• MDR Text Key: 136729451
• Report Number: 2183870-2019-00082
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/04/2019

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: 08/27/2021
• Device Catalogue Number: EVX35-06-150-150
• Device Lot Number: A698842
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/18/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 03/04/2019; 03/29/2019
• Supplement Dates FDA Received: 03/20/2019; 04/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/28/2018
• 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: 58 YR