MAUDE Adverse Event Report: COVIDIEN PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD; CATHETER, BILIARY, DIAGNOSTIC

Model Number	SERB65-09-40-80
Medical Device Problem Code	Inaccurate Delivery (2339)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/05/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The physician used the protégé gps 9x40 to treat a lesion in the great saphenous vein with 90% stenosis as per ifu.It was reported the stent was advanced with no resistance noted; the stent jumped and missed the target lesion.The physician used a 9x60x120 to extend the stent, to cover the lesion.The procedure was successful with no issues noted.No issues with either side of the stents.The extension was acceptable with no negative outcomes to the patient.No further clinical sequelae reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE GPS SELF-EXPANDING STENT SYSTEM 035 STANDARD
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 6192934
• Report Number: 2183870-2016-00741
• Device Sequence Number: 675601
• Product Code: FGE
• UDI-Device Identifier: 00821684071441
• UDI-Public: 00821684071441
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K050725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2016

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: 06/02/2019
• Device Model Number: SERB65-09-40-80
• Device Lot Number: A287394
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/05/2016
• Supplement Date Received by Manufacturer: 12/05/2016
• Initial Report FDA Received Date: 12/21/2016
• Supplement Report FDA Received Date: 09/28/2017
• 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
• Patient Age: 62 YR