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	02/04/2019
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 left basilic artery.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 post deployment.No excessive force was used.The physician completed the procedure by lining with a covered stent.
Additional Manufacturer Narrative
Additional information: the target treatment area was a venous occlusion in the patients mid left basilic vein.Pre-dilation was performed.No resistance was experienced when advancing the device.It is reported there was no injury to the patient that could not be repaired.Vessel damage was reported due to crushing of the stent which necessitated exclusion with covered stenting.The stent was reported to be crumpled during deployment.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cine image review: the first cine image evaluated showed the protégé stent deployed within the vessel.The distal and proximal tantalum markers were visible.It was noted the stent did not show full expansion.The stent struts were compressed inward against the lesion.The second cine image shows the protégé stent deployed with a second stent deployed within the protégé stent.Additional tantalum markers were identified outside of the protégé tantalum markers.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: 8420374
• Report Number: 2183870-2019-00131
• Device Sequence Number: 2249525
• 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): 06/26/2019

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: 09/25/2021
• Device Catalogue Number: SERB65-14-60-80
• Device Lot Number: A713811
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 03/14/2019; 06/25/2019
• Initial Report FDA Received Date: 03/14/2019
• Supplement Report FDA Received Date: 04/01/2019; 06/26/2019
• 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: 54 YR
• Patient Weight: 104