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

Catalog Number SECX-10-60-135

Device Problems Inadequacy of Device Shape and/or Size (1583); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/17/2016

Event Type  malfunction  

Manufacturer Narrative

Implant date: month, year.Valid.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A protege rx carotid stent was implanted in the right internal carotid artery on (b)(6) 2015.There was no issue noted during the index procedure.The physician checked and confirmed the stent was not deformed at the end of the procedure.Approximately 6 months post index, the patient visited the hospital for a 6 month follow-up.Through the angiographic image, the distal of the stent seemed was deformed inward and longitudinally from the middle to the distal end.The struts in the middle seemed to be damaged.Suspecting external forces, the physician asked the patient if the cervical area was being pressed or pressured sometime between the procedure and the follow up, and the patient denied.Current patient condition: fine, no complications.

Manufacturer Narrative

Additional information: the lesion exhibited 77% stenosis, almost no calcification or tortuosity.Vessel diameter: distal: 5.5 mm/ proximal: 8.4 mm.The number of prescribed antiplatelet tablets will be 2 from 1.Cine image review: 43 ct scans and videos from the procedure were received for evaluation.Angiography video clip1 and clip 2 shows protégé rx stent implanted in the carotid.Due to the vessel anatomy, the stent is not fully dilated in several areas of the stent.The stent does not exhibit any folding of the stent material.The vessel exhibits a slight curvature.Video 3 shows a frontal view of pre ¿angio scan of the guide wire advancement.Video 4 shows a side view pre ¿angio scan of the guide wire advancement.Video 5 shows a frontal view of the stent implanted into the vessel.Due to the vessel anatomy, the stent is not fully dilated in several areas of the stent.The stent does not exhibit any folding of the stent material.The vessel exhibits a slight curvature.Video 6 shows a side view of the stent implanted into the vessel.There is evidence of folding of the distal end of the stent.Seven ct scans show images of the implanted stent in the carotid artery: image 1 ct scan showing a radial cross section of the proximal end of the stent showing marker hoops.Image 2 ct scan shows a radial cross section of the proximal end of the stent (hearthside).The vessel and stents are observed to be concentric.Image 3 shows radial cross section of the proximal end of the stent, (oval shape).They are observed to be non-concentric.Image 4 shows radial cross section of the proximal end of the stent (bean shape).Vessels and stent are non ¿concentric.Image 5 shows radial cross section of the proximal end of the stent (bean shape) bifurcated into two chambers.Image 6 shows the profile of the stent exhibited a bean shape.The vessels and the stent are non-concentric.Image 7 shows the distal end of the stent (brain side).The profile of the stent exhibited a bean shape.The vessel and stent are n on-concentric.Per the initial event, the vessel at the proximal end of the stent is 8.4mm and the vessel at the distal end stent is 5.5mm.The stent size and recommended vessel luminal diameter is provided on the shelf carton label and product pouch label.From the images, an oversized stent was used for the vessel.

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: 5798557
• MDR Text Key: 49683509
• Report Number: 2183870-2016-00535
• 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: 10/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2017
• Device Catalogue Number: SECX-10-60-135
• Device Lot Number: A083723
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2016
• Date Device Manufactured: 04/03/2015
• 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