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

Catalog Number EVX35-06-040-120

Device Problem Premature Activation (1484)

Patient Problem Injury (2348)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use an everflex entrust pta balloon along with non medtronic 6fr sheath and 0.035 guide wire during procedure to treat a severely calcified lesion in the right distal sfa with 70% stenosis.Vessel is none tortuous.The vessel diameter and lesion length are 5mm and 3-4cm respectively.The device was prepped per ifu with no issues identified.It was reported that the stent was deployed in an unintended lesion site.The stent partially deployed (1cm of the tip of the stent was released) before reaching the target lesion and without pulling the lock pin, physician did not intend to release the stent there.The lesion was not pre dilated.The device did not pass through a previously deployed stent.Resistance was encountered when advancing the device with no excessive force used.After the partial deployment of the stent proximal to the target lesion, physician deployed the stent completely at that point (distal part of sfa).Physician decided to use a non medtronic stent (6x80), to cover both the everflex stent and the target lesion.It was not easy to push the catheter forward due to the cross over intervention.The iliac and all parts of sfa were severely calcified.There was no patient injury reported.

• 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 ; IE ; 091708734
• MDR Report Key: 9812628
• MDR Text Key: 195389733
• Report Number: 2183870-2020-00075
• 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
• Report Date: 03/10/2020

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: 09/18/2020
• Device Catalogue Number: EVX35-06-040-120
• Device Lot Number: A526514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2020
• Initial Date FDA Received: 03/10/2020
• Date Device Manufactured: 09/19/2017
• 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: 91 YR
• Patient Weight: 60