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

Catalog Number EVD35-06-100-120

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 04/26/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

The physician was using an everflex entrust with a 6mm spiderfx to treat a calcified lesion with 90% stenosis in the mid/proximal superficial femoral artery (sfa).There was no damage to the device packaging and no issues when removing the device from its packaging.The device was prepped with no issues identified.The lesion was predilated using a 5mm device.The device did not pass through a previously deployed stent and no resistance was encountered during advancement of the device.It was reported that the stent only deployed halfway and the patient was transferred to hospital to have the stent surgically removed.

• 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: 8594628
• MDR Text Key: 144543255
• Report Number: 2183870-2019-00238
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051375
• UDI-Public: 00821684051375
• 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
• Report Date: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2021
• Device Catalogue Number: EVD35-06-100-120
• Device Lot Number: A646640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/07/2019
• Date Device Manufactured: 05/16/2018
• 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