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

Model Number EVD35-07-150-150

Device Problem Positioning Problem (3009)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/31/2020

Event Type  malfunction  

Manufacturer Narrative

The entrust stent delivery system, (sds), was received within a sealed tyvek pouch, within a sealed plastic biohazard pouch, and loosely coiled within a zipper closure plastic biohazard pouch, along with a 0.014¿ guidewire.The entrust sds was received with the red safety tab removed from the handle, locked up on the 0.014¿ guidewire, the inner guidewire lumen folded up within the safety tab cavity of the handle, and approximately 2mm of the stent exposed.If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use a pacific xtreme pta balloon with a 6fr non-medtronic sheath and non-medtronic guidewire during treatment of a 200mm calcified lesion in the patient¿s mid left superficial femoral artery (sfa) of diameter 6mm.Slight vessel tortuosity and severe calcification is reported.No damage noted to product packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.The device was not passed through a previously deployed stent.No resistance is reported during advancement of the device.50/50 saline/contrast mix was used for balloon inflation.It is reported that a balloon burst occurred during inflation of the balloon.Balloon did not fragment.No vessel damage was noted.The balloon was safely removed from the patient without intervention.The physician then decided to treat with an everflex entrust self-expanding stent system using the same sheath and wire.No damage noted to product packaging prior to use.No issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.No resistance was encountered during advancement.It is reported the everflex entrust stent was unable to cross the lesion.The device was safely removed from the patient.The physician then used a non-medtronic stent to complete the procedure.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 ; IE ; 091708734
• MDR Report Key: 10074627
• MDR Text Key: 195543223
• Report Number: 2183870-2020-00148
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051719
• UDI-Public: 00821684051719
• 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: 05/20/2020

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: 03/21/2022
• Device Model Number: EVD35-07-150-150
• Device Catalogue Number: EVD35-07-150-150
• Device Lot Number: A803040
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/14/2020
• Initial Date FDA Received: 05/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/22/2019
• 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