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	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/20/2018
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 was attempting to use a protege gps stent to treat a lesion.The vessel was not tortuous.The lesion was not pre-dilated.There was no resistance advancing the device.During the delivery of the stent positioning difficulties were encountered.During deployment the delivery system jammed and the stent deployed outside the target lesion.Another medtronic device was used to complete the procedure.
Additional Manufacturer Narrative
Lot a258987 was not returned for analysis.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: 7373540
• Report Number: 2183870-2018-00184
• Device Sequence Number: 19119193
• Product Code: FGE
• UDI-Device Identifier: 00821684071786
• UDI-Public: 00821684071786
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K042204
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2018

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: 04/11/2019
• Device Catalogue Number: SERB65-14-80-80
• Device Lot Number: A258987
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/26/2018
• Initial Date Received by Manufacturer: 02/27/2018
• Supplement Date Received by Manufacturer: 04/26/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 05/24/2018
• 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