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

Catalog Number	PRB35-08-060-120
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	09/26/2017
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
The physician was attempting to use a protege everflex self-expanding to treat a severely calcified 50 mm lesion in the left common iliac artery.The artery was 7 mm in diameter and severely tortuous.The device was prepped as per the ifu with no issues identified.The procedure used a 6 fr non-medtronic sheath and a 0.035" non-medtronic guidewire.The lesion was pre-dilated using a 5x40 pta balloon.The protege everflex stent did not pass through a previously deployed stent and the physician was not met with resistance during advancement.It was reported that following the stent deployment, the physician experienced difficulty removing the device and the delivery catheter was caught on the stent upon withdrawal.Surgical cut down was required to remove the device.The patient was reported to be doing well.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6978928
• Report Number: 2183870-2017-00467
• Device Sequence Number: 18943531
• Product Code: FGE
• UDI-Device Identifier: 00821684069523
• UDI-Public: 00821684069523
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2017

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: 02/03/2020
• Device Catalogue Number: PRB35-08-060-120
• Device Lot Number: A410078
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2017
• Initial Report FDA Received Date: 10/25/2017
• 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