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

Catalog Number	SERB65-14-60-80
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/21/2019
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 using a protégé gps stent to treat a 60mm soft tissue lesion chronic total occlusion (cto) with little calcification in the mid right basilic axillary junction.Little tortuosity was reported and the vein diameter was 12-14mm.No abnormalities were reported in relation to anatomy.There was no damage to the device packaging and no issues when removing the device from the hoop/tray.The device was prepped as per ifu with no issues.Stent deformation was reported during positioning/deployment.The stent did pass through a previously deployed stent.The physician completed the procedure with a fluency covered stent.
Additional Manufacturer Narrative
Additional information: no resistance was experienced when advancing the device and no excessive force was used.It is reported there was no injury to the patient that could not be repaired.Vessel damage is reported due to crushing of the stent which necessitated exclusion with covered stenting.The type of damage seen to the stent was reported to be crushing.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review two cine images were provided.The first image shows two implanted stents.It is evident the stents are not within the same vessel because the visible guidewire does not track though the with even spacing between the stent struts.The tantalum markers at both end of the stent shows no anomalies.The stent that is over the loaded guidewire shows one end of the stent compressed and narrow spacing between the stent struts.The tantalum markers at the area of observed compression were grouped together in close proximity.Within the vessel cine shows a white cloudy appearance within the vessel where the stent appears compressed.The white cloudy appearance was likely the lesion attempting to be treated.The other end of the stent was not in an area compromised by the suspected lesion.The stent appeared fully expanded with even spacing between the tantalum markers.The second image shows the same characteristics as the first image provided; however an additional stent is observed.The additional stent was deployed at the same area of the previously deployed stent that showed signs of compression.The cine provided did not show a significant difference to the lesion.Additional tantalum markers were observed overlapping the previously deployed stent at both ends.The additional stent deployed was the same length as the previously deployed stent.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: 8420276
• Report Number: 2183870-2019-00130
• Device Sequence Number: 19393642
• Product Code: FGE
• UDI-Device Identifier: 00821684071762
• UDI-Public: 00821684071762
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K032580
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/14/2019

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: 10/15/2021
• Device Catalogue Number: SERB65-14-60-80
• Device Lot Number: A724403
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/14/2019; 06/06/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/01/2019; 06/14/2019
• 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: 53 YR
• Patient Weight: 105