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

Model Number PXB35-08-37-080

Device Problems Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problem Unspecified Tissue Injury (4559)

Event Date 05/13/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician attempted to use a visipro balloon expandable stent during treatment of a calcified lesion in the patient¿s mid common iliac artery.Slight vessel tortuosity and moderate calcification are reported.There was no damage noted to packaging (i.E.Shelf carton, hoop/tray).There were no issues noted when removing the device from the hoop/tray.Ifu was followed and the device was prepped with no issues identified.Pre-dilation was performed.The device was not passed through a previously deployed stent.Resistance was noted during advancement, but no excessive force was used.It is reported stent deformation occurred in vivo during positioning.The stent was removed using a snare.A second stent was opened and advanced.When the stent was in the target location it is reported the c-arm malfunctioned and the stent was pulled out and not deployed.Patient is alive with no injury and the procedure was completed.

Manufacturer Narrative

Additional information: no vessel damage noted.The device was removed from patient safely.Second stent used was a medtronic stent.No issue reported with second stent.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

Device evaluation the device was returned with no stent on the balloon.Stent was returned in a curved state and with damage to one end.The imprint of the stent is present on the balloon.The deployment system showed no damage, and the balloon is in a pre-inflated state.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: 11854260
• MDR Text Key: 251810370
• Report Number: 2183870-2021-00192
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00643169787872
• UDI-Public: 00643169787872
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 09/16/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: PXB35-08-37-080
• Device Catalogue Number: PXB35-08-37-080
• Device Lot Number: A902690
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 06/01/2021; 09/10/2021
• Supplement Dates FDA Received: 06/09/2021; 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention