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

Catalog Number	PRB35-07-080-120
Medical Device Problem Codes	Fracture (1260); Positioning Problem (3009)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	07/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem 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.
Additional 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
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8801824
• Report Number: 2183870-2019-00375
• Device Sequence Number: 327508
• Product Code: NIO
• UDI-Device Identifier: 00821684069370
• UDI-Public: 00821684069370
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 07/16/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 07/18/2019
• Supplement Report FDA Received Date: 07/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention