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

Catalog Number EVD35-08-040-080

Device Problems Entrapment of Device (1212); Activation, Positioning or Separation Problem (2906)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 07/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the physician intended to use an everflex entrust to treat a 40mm calcified cto (chronic total occlusion - 100%) in the patient¿s distal right common iliac artery.The vessel diameter was reported to be 7mm.A non-medtronic 6f sheath and a non-medtronic 0.035 wire were used.The lesion was reported to be of moderate tortuosity and calcification.The ifu was followed and the device was prepped without issue.The thumbscrew/lock-pin was checked for securement prior to procedure.Embolic protection was not used.Pre-dilation was carried out using an 8mm pre-dilation device.It was reported that deployment issues occurred when the red safety was pulled prior to deployment - it became caught on a wire and the stent deployed on its own.The stent was reported to have deployed in the correct area.

Manufacturer Narrative

Additional information: there was no patient injury reported.Evaluation summary: the everflex entrust stent delivery system, (sds), was received for evaluation.No ancillary devices from the procedure were received for evaluation.The returned entrust sds showed the red safety tab and tube were not fully removed.The pull cable was found to wrapped around the red safety tube and inner guidewire lumen.This would have occured due to multiple rotations of the stent delivery system prior to attempts to deploy the stent.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: 7734263
• MDR Text Key: 115658110
• Report Number: 2183870-2018-00403
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051276
• UDI-Public: 00821684051276
• 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: 10/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Catalogue Number: EVD35-08-040-080
• Device Lot Number: A621006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/24/2018
• Initial Date FDA Received: 07/31/2018
• Supplement Dates Manufacturer Received: 08/08/2018; 09/12/2018
• Supplement Dates FDA Received: 10/02/2018; 10/10/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2018
• 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 Age: 72 YR