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

Catalog Number	PRB35-07-120-120
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	11/15/2018
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
The physician intended to use the protégé everflex 7x120 with a non-medtronic 6fr sheath and a non-medtronic guidewire to treat a moderately calcified fibrous 95% stenosed lesion in the left distal common iliac artery.The device was prepped as per ifu with no issues identified.Artery diameter 6mm, lesion length 120mm, the lesion was not pre-dilated, no resistance or excessive force was used.It was reported the stent fractured during deployment at the lesion site, 1/3 of the stent remains in the patient the remaining stent was removed from the patient within the catheter housing.Another protégé everflex 7x80 was used to complete the procedure.No patient injury was reported.
Additional Manufacturer Narrative
Device evaluation: visual inspection: the protégé everflex was removed from the bag and inspected.A portion of a fractured stent was identified protruding out from the distal outer portion of the catheter.The exposed struts of the stent were stretched distally.Approximately 6cm of the inner assembly was protruding out from the outer.No damage to the exposed inner was identified: however a bend to the catheter shaft at the area of the proximal end of the stent was identified.A sharp bend to the catheter shaft approximately 33 cm from the distal end was identified.The hypotubing was curved between the deployment grips.The locking screw was loose.Direct light applied to the distal end of the catheter showed approximately 6cm of the stent remained loaded the catheter.Functional testing.A gw could not be loaded due to the observed damage to the catheter shaft.The deployment grips were pulled together while encountering resistance.The stent would not deploy.If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM LONG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8119481
• Report Number: 2183870-2018-00552
• Device Sequence Number: 1656915
• Product Code: FGE
• UDI-Device Identifier: 00821684060131
• UDI-Public: 00821684060131
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K072301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/08/2019

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: 05/29/2021
• Device Catalogue Number: PRB35-07-120-120
• Device Lot Number: A653002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2018
• Initial Date Received by Manufacturer: 11/15/2018
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 11/30/2018
• Supplement Report FDA Received Date: 02/08/2019
• 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: Other
• Patient Age: 81 YR