MAUDE Adverse Event Report: COVIDIEN PROTEGE RX CAROTID STENT SYSTEM; STENT, CAROTID

Catalog Number SECX-10-60-135

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/10/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

The physician was attempting to use a protege rx carotid stent peripheral self-expanding stent to treat carotid artery stenosis.The vessel was reported to be slightly tortuous and small in diameter.After the protege stent was placed in the target lesion, 3d ct was taken.When the physician checked the image, the stent looked like a heart shape.It was not seen on the angiographic image taken prior.However, the physician checked the angiographic image very carefully, and saw a slight line on the cc through the branch of ec, which seemed to be overlapped with the location of the moma shaft used during the intervention.No intervention required, no clinical sequelae reported.

Manufacturer Narrative

A series of 24 3d ct scan images were received for evaluation.The 3d ct scan image 1: view of the stent from the base.Stent appears to be fully expanded with apposition to the vessel wall.The 3d ct scan image 2: longitudinal veiw of the stent.Vessel and stent appear to bend to the left.A sharp focal lesion approximately half the length of the stent, (¿ 30mm),appears to be pushing the stent into the vessel lumen.The 3d ct scan image 3: longitudinal veiw rotated.At the base of the stent in this focal plane one of the radioplaque marker hoops is visiable.The 3d ct scan image 4: longitudinal veiw of the stent rotated to patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The 3d ct scan image 5: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent two radioplaque markers are visible.At the top two stent radioplaque markers are visible.What appears to be an opening at the top of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 6: longitudinal veiw of the stent patient¿s right side, rotated more to the right.Vessel and stent appear to bend to the left in this focal plane.The focal plane depth has changed.In this focal plane at the base of the stent four radioplaque markers are visible.At the top no stent radioplaque markers are visible.What appears to be an opening at the top of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 7: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent four radioplaque markers are visible.At the top two stent radioplaque markers are visible.What appears to be an opening at the top of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 8: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent three radioplaque markers are visible.At the top two stent radioplaque markers are visible.What appears to be along the length of most of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 9: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent one radioplaque marker is visible.At the top two stent radioplaque markers are visible.What appears to be an opening at the top of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 10: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.The focal plane depth has changed.In this focal plane at the base of the stent one radioplaque marker is visible.At the top no stent radioplaque markers are visible.What appears to be an opening at the top of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 11: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent one radioplaque marker is visible.At the top no stent radioplaque markers are visible.What appears to be an opening along the length of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 12: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent four radioplaque markers are visible.At the top two stent radioplaque markers are visible.What appears to be an opening at the top of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 13: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent no radioplaque markers are visible.At the top two stent radioplaque markers are visible.What appears to be an opening along the length of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 14: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent no radioplaque markers are visible.At the top one stent radioplaque marker is visible.What appears to be an opening along the length of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 15: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent no radioplaque markers are visible.At the top one stent radioplaque marker is visible.What appears to be an opening along the length of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 16: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.The focal plane depth has changed.In this focal plane at the base of the stent five radioplaque markers are visible.At the top four stent radioplaque markers are visible.The 3d ct scan image 17: longitudinal veiw of the stent patient¿s right side.Vessel and stent appear to bend to the left in this focal plane.A sharp focal lesion approximately half the length of the stent, (¿ 30mm), appears to be pushing the stent into the vessel lumen.The focal plane depth has changed.In this focal plane at the base of the stent no radioplaque markers are visible.At the top two stent radioplaque markers are visible.What appears to be an opening along the length of the stent is caused by that portion of the stent being above or below the focal plane of the cine.The 3d ct scan image 18: axial view of the stent.Five stent radioplaque markers are present.One of the radioplaque markers appears to be out of position and pushed into vessel lumen.The 3d ct scan image 19: axial view of the stent.The focal depth and plane has changed.No stent radioplaque markers are present.The axial stent profile appears to be heart or bean shaped, (pushed into vessel lumen).The 3d ct scan image 20: axial view of the stent.The focal depth and plane has changed.No stent radioplaque markers are present.The axial stent profile appears to be heart or bean shaped, (pushed into vessel lumen).The 3d ct scan image 21: axial view of the stent.The focal depth and plane has changed.No stent radioplaque markers are present.The axial stent profile appears to be heart or bean shaped, (pushed into vessel lumen).The 3d ct scan image 22: axial view of the stent.The focal depth and plane has changed.No stent radioplaque markers are present.The axial stent profile appears to be heart or bean shaped, (pushed into vessel lumen).The 3d ct scan image 23: axial view of the stent.The focal depth and plane has changed.No stent radioplaque markers are present.The axial stent profile appears to be heart or bean shaped, (pushed into vessel lumen).The 3d ct scan image 24: axial view of the stent.The focal depth and plane has changed.No stent radioplaque markers are present.The axial stent profile appears to be heart or bean shaped, (pushed into vessel lumen).Using 3d ct scan image 16 a ratio comparison of the length of stent (60mm) to the length of the image of the stent (approximately 5 inches) was used to determine that the base of the stent is approximately 9mm in diameter, the narrowest part of the stent is approximately 4.5mm in diameter and the top of the stent is approximately 7.5mm in diameter.This indicates that the stent was not properly sized for the vessel: per the ifu a 10mm stent should be used with vessel with a luminal diameter of 8.5mm to 9.5mm.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: PROTEGE RX CAROTID STENT SYSTEM
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5717001
• MDR Text Key: 47165284
• Report Number: 2183870-2016-00393
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P060001
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/09/2017
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A119001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2016
• Date Device Manufactured: 06/10/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 46 YR