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 Retraction Problem (1536); Activation Problem (4042)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/16/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that the physician was using an everflex entrust stent to treat a severely calcified, slightly tortuous chronic total occlusion (cto)100% stenotic, fibrous, calcified lesion in the proximal superficial femoral artery(sfa).There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped per ifu without issue.No embolic protection was used.The vessel was not pre-dilated.The device did not pass through a previously deployed stent during delivery of the device to the lesion.It was reported that the stent partially deployed at the lesion site.The physician broke open the handle and used a simple pin and pull technique to deploy the stent.The system then became difficult to remove from the patient.The physician used a scalpel to peel away the inner deployment sheath from.035 glide wire.The deployment system was then removed without incident.Post dilatation was carried out and another everflex entrust stent was deployed distal to this stent without any incident.There was no patient injury reported.

Manufacturer Narrative

Additional information: the stent wsa deployed at the intended target lesion.The patient was discharged without any issue.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Product analysis: the everflex entrust was returned.No ancillary devices were included.The everflex entrust was returned with several components det ached/fractured from one and other.The handle assembly was broken open and the red locking pin was removed.The first assembly inspected was the outer which remained connected to one half of the handle assembly.The stent was not loaded/returned.6 kinks were noted.The proximal end of the silver outer is frayed at the location where the pull cable was previously attached.It was verified the stent was not loaded.The inner assembly/pusher was fractured apart.A kink was observed.The fracture face showed a straight edge consistent with the appearance of being cut by a sharp instrument.The thumb wheel which showed the pull cable connected was analysed.The tip of the exposed pull cable was frayed.The proximal segment of the inner assembly which was connected to the clear luer was inspected.The distal fracture face was straight.Buckling was noted.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: 8712104
• MDR Text Key: 148423283
• Report Number: 2183870-2019-00340
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/17/2022
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A833850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2019
• 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