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	Malposition of Device (2616)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Patient Problem/Medical Problem (2688)
Date of Event	06/15/2018
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
Physician intended to use a protégé everflex with a 6f non-mdt sheath and a stiff angled guidewire for treatment of a 45mm plaque lesion in the patients proximal left external iliac of diameter 7mm.Lesion exhibited 70% stenosis.Slight calcification and moderate tortuosity were reported.Embolic protection was not used.Ifu was followed.Device was prepped without issue.The lesion was not pre-dilated.The device did not pass through a previously deployed stent and no resistance was encountered when advancing the device.It is reported the stent deployed within a short 10cm sheath.When the physician pulled back the sheath the stent deployed in the wrong area (left common femoral artery) and a quarter of it was not within the artery.A cut-down was performed to remove the stent from the left common femoral artery.The procedure was completed at this point.The patient is doing well.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 7684987
• Report Number: 2183870-2018-00377
• Device Sequence Number: 1397926
• Product Code: FGE
• UDI-Device Identifier: 00821684069523
• UDI-Public: 00821684069523
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K060057
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/05/2018

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: 07/18/2020
• Device Catalogue Number: PRB35-08-060-120
• Device Lot Number: A493790
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/15/2018
• Supplement Date Received by Manufacturer: 07/13/2018; 08/08/2018
• Initial Report FDA Received Date: 07/13/2018
• Supplement Report FDA Received Date: 08/08/2018; 10/05/2018
• 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
• Patient Age: 74 YR
• Patient Weight: 90