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	05/15/2019
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
It was reported that the physician intended to use a fortrex pta balloon to pre-dilate a non calcified, moderately tortuous lesion in the mid left brachial/axillary avf.There was no damage noted to the packaging and no issues noted when removing the device from the tray.A non-medtronic sheath was used with a 0.035 guidewire without embolic protection and with saline/heparin as inflation fluid.The device was prepped however contrast was observed leaking from the base of the hub.This device was not used in the patient.Another fortrex pta balloon was used to successfully pre-dilate the lesion.A protégé gps was deployed at the lesion site.On follow up, approximately 1month later, it was observed, under angiogram, that the stent had deformed.A non-medtronic covered stent was used to deal with the deformed stent.There was no patient injury reported.
Additional Manufacturer Narrative
Additional information: a non-medtronic stent was used to reline with the deformed stent.The physician reported that difficulty was encountered deploying stents when there is a significant caliber in size on either side of the lesion.The patient is reported to be well.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Image review: two photographs from one-month post follow-up cine images were received.Three deployed stents can be identified in the cines.In the first photograph of a cine image due to the quality and clarity of the image it is not possible to see the individual cell struts of the stent.In the second image individual cell struts rows can be seen in the mid left brachial/axillary arteriovenous fistulas (avf).The left most stent in the cine image appears to have stent cell elongation, possible stent cell fracturing, and the left end of the stent appears to have expanded to a larger diameter than the other two stents in the cine image.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
(b)(4).It was reported that there was a leak at the hub, through the port, of the fortrex balloon.-###-from (b)(4).It was reported that a protege stent became deformed and caused a patient's graft to thrombose, 1 month post graft implant.

• 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: 8631963
• Report Number: 2183870-2019-00296
• Device Sequence Number: 1655740
• 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: K050725
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/13/2019

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: 11/29/2021
• Device Catalogue Number: SERB65-14-60-80
• Device Lot Number: A747187
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/16/2019
• Supplement Date Received by Manufacturer: 05/23/2019; 08/09/2019
• Initial Report FDA Received Date: 05/22/2019
• Supplement Report FDA Received Date: 05/28/2019; 08/13/2019
• 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: 76 YR
• Patient Weight: 84