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

Catalog Number	SERB65-14-80-80
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	03/30/2017
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 intended to use a protégé gps stent during procedure for treatment of the left limb.There was no damage noted to the packaging.There were no issues when removing the device from the hoop/tray.The device was prepped with no issues identified.It is reported that stent dislodgement occurred.The stent was deployed and post dilated with a balloon.As the balloon was being removed, the stent caught on the balloon and moved.The stent was not removed.No resistance was encountered when advancing the device and excessive force was not used.Stent migrated with balloon inflation.
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: 6529263
• Report Number: 2183870-2017-00191
• Device Sequence Number: 10979582
• Product Code: FGE
• UDI-Device Identifier: 00821684071786
• UDI-Public: 00821684071786
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P060001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2017

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: 01/24/2020
• Device Catalogue Number: SERB65-14-80-80
• Device Lot Number: A404806
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/30/2017
• Supplement Date Received by Manufacturer: 03/30/2017
• Initial Report FDA Received Date: 04/28/2017
• Supplement Report FDA Received Date: 10/03/2017
• 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: Hospitalization
• Patient Age: 80 YR
• Patient Weight: 47