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

Catalog Number	SERB65-14-20-80
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	11/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No protege stent delivery systems, ancillary devices or procedural summaries from the procedures were received.A single photographic image of a cine image was provided for evaluation.The cine image is of the deployed gps 14mm by 20mm at the ostium of the saphenous vein.Less than half of 20mm length stent is in apposition with the vein wall.A guidewire is visible in the cine and runs through the center of the stent.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use the protégé gps a 6fr non-medtronic sheath and a 3j non-medtronic guidewire to treat a lesion at the mid short saphenous vein.No tortuosity was reported.As per ifu with no issues identified.The lesion was not pre-dilated, no resistance or excessive force was used.It was reported the stent jumped and was deployed at an unintended lesion site, the physician attempted to use a second stent to overlap the deployed stent but was unable as the first stent dislodged before it could be deployed.A snare was used to retrieve the dislodged stent.All components were removed from the patient.The patient did not receive the second stent.

• 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: 8123868
• Report Number: 2183870-2018-00553
• Device Sequence Number: 1721456
• Product Code: FGE
• UDI-Device Identifier: 00821684071700
• UDI-Public: 00821684071700
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K050725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2018

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: 09/05/2021
• Device Catalogue Number: SERB65-14-20-80
• Device Lot Number: A703236
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/16/2018
• Initial Report FDA Received Date: 12/03/2018
• 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
• Patient Age: 74 YR