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

Model Number PXB35-07-17-080

Device Problems Deflation Problem (1149); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2022

Event Type  malfunction  

Event Description

Physician was attempting to use a visi pro balloon expandable stent along with a non-medtronic 6fr sheath during procedure to treat a moderately calcified lesion in the right biliary artery and common iliac artery.The vessel was little tortuous.No embolic protection used.There was no damage noted to packaging.There was no issue noted when removing devices from hoop/tray.The devices were prepped per the ifu with no issues identified.The first visi pro was inaccurately delivered (that is, stent deployed in unintended lesion site).There was sufficient landing zone.The stent was fully expanded.It came off the balloon at the external iliac en route to the renal artery.It was then deployed in this position.There was an attempt made to remove the stent.It is unknown if there was deformation noted on the stent.The lesion was not pre dilated.The first device did not pass through a previously deployed stent.There was resistance encountered when advancing the device with no excessive force used.Another stent was selected, pxb35-07-17-080, delivered to target lesion and deployed.The second visi pro, balloon deflation difficulties occurred with the device slow to deflate at the lesion site.It is unknown how long it took to deflated the balloon.It looks as though the balloon was fully deflated prior to removal.The stent remains in the patient.There was no deformation noted to the deployed stent.The lesion was pre dilated with an unknown 3mm balloon.The device did not pass through a previously deployed stent.There was no resistance encountered when advancing the device.It was reported that the stent was deployed at the target lesion.There was no resistance after balloon deflation and when attempting to remove the balloon from the lesion area.The balloon was finally removed without incidence, however, it took many attempts.The stent was deployed in the target lesion, the renal artery accurately.There was only difficulty in removing the balloon, but it eventually came out.There was no patient injury reported.

Manufacturer Narrative

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

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
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 14276427
• MDR Text Key: 299369272
• Report Number: 2183870-2022-00165
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00643169787759
• UDI-Public: 00643169787759
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030045
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/10/2023
• Device Model Number: PXB35-07-17-080
• Device Catalogue Number: PXB35-07-17-080
• Device Lot Number: B115610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Date Device Manufactured: 11/10/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Male