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

Catalog Number EVX35-05-080-120

Device Problems Positioning Problem (3009); Activation Problem (4042)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/06/2019

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, 80% stenotic lesion in the mid 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 device did not pass through a previously deployed stent and no resistance was encountered and no excessive force was applied during delivery of the device to the lesion.The thumbscrew was checked for securement prior to the procedure and the lock-pin was removed just before deployment.It was reported that the stent partially deployed in an unintended lesion.The physician deferred to surgery to remove the stent and treat the severely stenotic sfa.The patient is currently doing well.

Manufacturer Narrative

Additional information: the stent was removed from the patient's artery via open surgery.The patient has been discharged and is currently doing well.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: the device was successfully advanced to the target lesion prior to removing the lock tube and attempted to deploy.Deployment difficulties were encountered.The stent is reported to have wrinkled.If information is provided in the future, a supplemental report will be issued.

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 STANDARD
• 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: 8716773
• MDR Text Key: 148566052
• Report Number: 2183870-2019-00341
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 09/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/16/2021
• Device Catalogue Number: EVX35-05-080-120
• Device Lot Number: A630885
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2019
• Date Device Manufactured: 04/17/2018
• 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