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 Difficult or Delayed Positioning (1157); Stretched (1601)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/17/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use an everflex entrust to treat a severely calcified cto in the distal superficial femoral artery.A 6f sheath and a 0.035¿, 260cm, guidewire were used and the device was prepared as per ifu.The lesion was pre-dilated using a 5mm device.The artery diameter was reported to be 6mm with a lesion length of 150mm.It was reported the physician encountered resistance & difficulties whilst deploying the stent as the deployment dial was not functioning correctly.As a result, the stent partially deployed & the physician had to manually deploy the stent, while removing the delivery system.The stent was reported to have elongated from 150mm to an approximation of 300mm.The physician was able to post dilate the stent, to good effect.No injury to the patient reported.No cine images are available.

Manufacturer Narrative

Evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation.No ancillary devices or cines from the procedure were received.The entrust sds was received with the red safety tab removed from the deployment handle.Neither the red safety tab nor the red safety tube was returned.The delivery catheter exhibited several kinks.The deployment handle safety tab cavity was examined.No pull cable was visible within the cavity.The inner guidewire lumen exhibited no abnormality or deformity within the cavity.The full working length of the deployment catheter was examined.There was a set of kinks noted approximately 26.2cm, 49.0cm, 52.0cm and 78.6cm from the distal tip of the sds.The proximal end of the sheath was noted approximately 122cm from the distal tip of the sds.The pull cable and inner guidewire lumen were visible between the proximal end of the outer sheath and the distal end of the isolation sheath.A series of kinks were noted in the isolation sheath at approximately 146.3cm, 152.9cm, and 178.5cm from the distal tip of the sds.The catheter was examined and the inner guidewire lumen and the pull cable were visible.The pull cable was still attached to the outer sheath.Further examination of the inner guidewire lumen and pull cable revealed approximately 15cm of pull cable remained attached to the outer sheath.The interior of the handle was examined and the pull cable was wrapped around the thumb wheel and the inner guidewire lumen exhibited zones of compression damage.The returned entrust sds exhibited a separation of the pull cable.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: 7517942
• MDR Text Key: 108371943
• Report Number: 2183870-2018-00276
• 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: 10/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2021
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A591753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/14/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/03/2018
• 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