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

Catalog Number EVD35-06-150-150

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used an everflex entrust with a 7f 45cm non-medtronic sheath during treatment of a calcified lesion in the patient¿s mid superficial femoral artery (sfa).Slight tortuosity and moderate calcification are reported.No damage noted to packaging or issue noted when removing device from packaging.Ifu was followed and the device was prepped without issue.Pre-dilation was not performed.The thumbscrew/lock-pin checked for securement prior to procedure.No resistance was encountered when advancing the device.The lock-pin was removed when physician was ready to deploy the stent.The physician attempted to deploy the stent, but deployment issues were experienced.The physician had to undo the handle of the stent delivery system and pull the sheath in order to fully deploy the stent.The stent was successfully deployed in the target ares.No further treatment was required.No patient injury reported.

• 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: 8127971
• MDR Text Key: 129350062
• Report Number: 2183870-2018-00560
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051634
• UDI-Public: 00821684051634
• 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: 12/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2021
• Device Catalogue Number: EVD35-06-150-150
• Device Lot Number: A690941
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2018
• Date Device Manufactured: 08/11/2018
• 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