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

Catalog Number	PRB35-05-120-120
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/02/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During an attempt to treat a fibrous totally occluded lesion using a protege stent, it was reported that the physician started by taking pictures of the totally occluded sfa to popliteal.It was reported that the physician then inserted a 6x5 sheath and then ballooned with an amplatz super stiff wire.The first stent - a 5x120 ¿ was inserted right at the hunters canal.Then another stent - a 5x120 ¿ was delivered.However, when the physician checked the screen he decided that something did not look right.So, he pulled the stent out and the nose cone was all the way into the outer sheath.On the back table, the stent was partially deployed to make sure it was still in the device.The physician then took the deployed stent and as the physician brought it out of the sheath, the nose cone broke off.The physician then changed the sheath out and used a 7x45 sheath.The procedure was completed using a 6x150 unknown stent.The physician then post dilated with an unknown device.There was no harm to the patient reported.
Additional Manufacturer Narrative
Device evaluation: the everflex device was inspected and observed the stent pre-deployed approximately 6.5cm.The finger grips were approximately 6cm apart.The distal tip, stent, exposed inner assembly, and outer was inspected under microscope and found no damages or anomalies.The hypotubing was detached from the catheter in the lab in order to inspect the device for witness marks.No clear visible witness marks were noted indicating the user tightened the safety knob prior to use.A good faith effort will be made to obtain the applicable information relevant to the report.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 LONG
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6222473
• Report Number: 2183870-2017-00010
• Device Sequence Number: 876291
• Product Code: FGE
• UDI-Device Identifier: 00821684068625
• UDI-Public: 00821684068625
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K072301
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/16/2019
• Device Catalogue Number: PRB35-05-120-120
• Device Lot Number: A328757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2017
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided; 01/06/2017
• Initial Report FDA Received Date: 01/04/2017
• Supplement Report FDA Received Date: 02/02/2017; 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1