MAUDE Adverse Event Report: COVIDIEN VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM; STENT, ILIAC

Catalog Number PXP35-07-37-080

Device Problems Fracture (1260); Migration or Expulsion of Device (1395); Improper or Incorrect Procedure or Method (2017)

Patient Problems High Blood Pressure/ Hypertension (1908); Injury (2348)

Event Date 06/04/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician implanted two visi pro during procedure to treat a severely calcified lesion in the right proximal common carotid artery (cca) with 90% stenosis.The vessel diameter is 7mm.It was reported that the stents were used to treat a severely calcified lesion of the common carotid artery.There were no issue with packaging or hoop tray.The device was prepped according to ifu.Access was brachial right.Arteries were quite tortuous, and a 6fr non-medtronic sheath to straightened the vessels.The lesion was not pre or post dilated.The longer stent was implanted first and result was suboptimal.Stent did not open enough so that a second stent was placed in the first one to obtain a satisfactory result.Patient recently complained about dizziness.Blood pressure showed quite uncontrollable.Ct scan was done and a piece of fractured stent was found to have migrated cranially.Patient has no adverse event but need to be operated to remove the stent piece.Patient had a very tight and severely calcified lesion of the common carotid artery which required the implantation of a visipro stent.As expansion was not satisfactory, a second visipro stent was placed inside the first one.Recently patient complained about dizziness and uncontrollable blood pressure and a ct scan was done.The scan showed stent fracture and cranial migration of the fractured part at the level of the bifurcation between cca and subclavian artery on the right side.The piece of stent is about 1cm long.This is not possible to retrieve it endovascularly.Bypass surgery between aorta and subclavia was recommended.No pressure is being made on the patient at the moment to go for surgery with emergency as there are no adverse events.No further patient injury reported.

Manufacturer Narrative

Corrected information: d2: product code additional information: stent fracture was of the first stent to be implanted, which was the longest one.Image review: technical analysis of the two photographs of cine images received was conducted.The first image of the two stents implanted.The stents were implanted in a ¿kissing¿ procedure with minimum to no overlap of the stainless-steel balloon expandable stent.Using anatomical landmarks within the first image the stents appear to be implanted within the rib cage in a subclavian artery.The upper most stent in the image is the shorter of the two stents appears to be fully expanded.The lower most stent the longer of the two stents appears to be not fully expanded in an area of a calcified lesion.The image includes a support sheath with distal radiopaque marker band, guidewire, and a pta device with radiopaque marker bands.The second image is of the two stents post-procedure.The uppermost stent in the image has migrated from its ¿kissing¿ position in the previous image.Using the anatomical landmarks, the stent has migrated ¿cranially¿.The stents radiopaque marker hoops can be seen at both ends of the stent.The stent does not exhibit any obvious stent fracturing.Due to the quality and clarity of the images individual stent strut rows cannot be easily identified.The lowermost stent, in the image appears to have an offset pseudo fracture.Based on the first image the offset pseudo fracture is in the area of the calcified lesion and appears to be a major off set.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

Manufacturer Narrative

Additional information: the devices were used to treat the innominate artery (brachiocephalic trunk), not the common carotid artery.The devices were used off-label.Hypertensive derailment was noted in the patient.Radiologically, there are no signs of intracranial bleeding; however, there are early signs of ischemia.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: VISI-PRO BALLOON-EXPANDABLE STENT SYSTEM
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10167968
• MDR Text Key: 195574760
• Report Number: 2183870-2020-00180
• Device Sequence Number: 1
• Product Code: NIO
• Combination Product (y/n): N
• PMA/PMN Number: P030045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2020
• Device Catalogue Number: PXP35-07-37-080
• Device Lot Number: A531249
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 69 YR