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

Catalog Number EVD35-06-100-150

Device Problems Kinked (1339); Mechanical Problem (1384); Therapy Delivered to Incorrect Body Area (1508); Activation, Positioning or Separation Problem (2906)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 09/22/2016

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 attempted to treat patient at the mid superficial femoral artery using a everflex entrust.It is reported that stent was deployed in an unintended lesion site.A second stent was used to treat the target lesion.No patient complications reported.

Manufacturer Narrative

Evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation.The 100mm stent was also received with the delivery system.No ancillary devices or cine images from the procedure were received for evaluation.A note on a card indicated that the stent would not deploy while in the patient.As a result of this note and the receipt of the actual stent, it can be concluded that the original report of the stent having been deployed in an unintended lesion was inaccurate.The 100mm stent was examined: no abnormality or deformity was noted.The entrust stent delivery system was received without its red locking safety tab and tube.Examination of the handle and locking safety tab cavity revealed no abnormality with the guidewire lumen and that the pull cable was present.The overall length of the stent delivery system(sds) was measured to be approximately 170 cm - the label claim of the overall length of this sds is 180cm.During the measurement a series of 58 kinks were noted within the isolation sheath and outer sheath starting approximately 119.5 cm distal of the handle¿s proximal hub luer lock to approximately 158.5 cm distal of the handle¿s proximal hub luer lock.The distal end of the guidewire lumen/pusher is approximately 50 mm proximal of the distal end of the sds outer sheath.

Manufacturer Narrative

It was confirmed that the stent was not implanted in the patient.Allegation is that physician was unable to deploy the stent as the sheath would not retract when the wheel was moved.

Manufacturer Narrative

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: 6041222
• MDR Text Key: 57861446
• Report Number: 2183870-2016-00645
• Device Sequence Number: 1
• Product Code: NIP
• 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,consum
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 01/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/16/2019
• Device Catalogue Number: EVD35-06-100-150
• Device Lot Number: A244268
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2016
• 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
• Patient Outcome(s): Other
• Patient Age: 62 YR