MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; STENT, ILIAC

Catalog Number PRB35-07-080-120

Device Problems Fracture (1260); Positioning Problem (3009)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 07/16/2019

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 physician was using a protege everflex stent to treat a slightly calcified, non tortuous lesion in the left proximal common iliac artery.There was no damage noted to the packaging and no issues noted when removing the device from the tray.The device was prepped per ifu with no issues identified.A 6fr non-medtronic sheath was used for the procedure with no embolic protection.The device did not pass through a previously deployed stent and no resistance was encountered or force applied during delivery of the device to the lesion.The thumbscrew was checked for securement prior to the procedure.It was reported that the physician completely unlocked the stent deployed it via pin and pull system however, approx.1-2cm remained undeployed and stuck in the deployment system.The sheath was used to push on the stent to try to release the remaining 1-2cm.The stent became pushed into the aorta and resulted in multiple stent fractures.The patient is scheduled for another procedure to stent and rebuild the bifurcation.

Manufacturer Narrative

The stent was pushed into the aorta resulting in elongation, the physician commented there could possibly be stent fractures in the future due to difficulty getting the stent fully deployed.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Type of Device: STENT, ILIAC
• 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: 8801824
• MDR Text Key: 151410353
• Report Number: 2183870-2019-00375
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00821684069370
• UDI-Public: 00821684069370
• 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
• Report Date: 07/29/2019

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: 08/22/2020
• Device Catalogue Number: PRB35-07-080-120
• Device Lot Number: A512907
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/18/2019
• Supplement Dates Manufacturer Received: 07/18/2019
• Supplement Dates FDA Received: 07/29/2019
• Date Device Manufactured: 08/23/2017
• 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