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 Fracture (1260); Material Deformation (2976)

Patient Problems Occlusion (1984); Patient Problem/Medical Problem (2688)

Event Date 02/21/2019

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 patient had an everflex entrust 6x150x120 stent implanted on (b)(6) 2019 to treat a severly calcified cto in the distal superficial femoral artery(sfa).On (b)(6) 2019 the physician attempted to use a 6x100 evercross to treat the occluded stent when a stent fracture was observed under flouroscopy.The physician was unable to carry out the intended angioplasty and the patient was scheduled for a bypass procedure.

Manufacturer Narrative

Image review: a cine image of the reported implanted stent.The cine image showed an implanted stent which shows likely shows evidence of stent elongation.A fracture of the stent could not be conclusively identified.The cine shows the implanted stent with adequate spacing of the stent struts, but at the suspected calcified lesion the struts of the stent appear to have wider spacing between struts in the distal direction.The distal end of the stent with the tantalum spheres were not identified at the distal end of the stent.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information: there was nothing unusual noted in the stent implantation procedure.It is unknown when the bypass procedure will be carried out.The patient is reported to be stable.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: 8393981
• MDR Text Key: 137930105
• Report Number: 2183870-2019-00117
• 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: 06/13/2019

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: 04/23/2021
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A635127
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2019
• Initial Date FDA Received: 03/06/2019
• Supplement Dates Manufacturer Received: 03/06/2019; 06/04/2019
• Supplement Dates FDA Received: 03/20/2019; 06/13/2019
• Date Device Manufactured: 04/24/2018
• 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
• Patient Age: 88 YR