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

Model Number PXB35-05-17-080

Device Problems Malposition of Device (2616); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923); Material Deformation (2976)

Patient Problems Device Embedded In Tissue or Plaque (3165); Unspecified Tissue Injury (4559)

Event Date 08/02/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician was attempting to use the visi-pro balloon expandable peripheral stent during procedure to treat the mid left renal artery.The left renal artery had a previous non medtronic stent and imaging showed restenosis.The physician was attempting to extend the stented segment by placing the 5 x 17mm vis-pro stent.A non-medtronic wire and 6fr sheath were used.The sheath was placed in the existing non medtronic stent.The 5x17mm visi-pro stent was loaded on the wire and pushed through the 6fr sheath.The stent became dislodged and came off the balloon.The attempts to push the balloon into the stent were unsuccessful.An attempt was made to snare the stent but while the snare got around the stent the stent deformed a little.It was decided to complete the procedure by leaving the stent and placing the patient on anticoagulants. the un-deployed stent was left distal to the existing stent.The physician made the statement of possible renal infarction of the left kidney but this is unconfirmed.

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
• MDR Report Key: 12301215
• MDR Text Key: 265821672
• Report Number: 2183870-2021-00287
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00643169787575
• UDI-Public: 00643169787575
• 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
• Report Date: 10/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/29/2023
• Device Model Number: PXB35-05-17-080
• Device Catalogue Number: PXB35-05-17-080
• Device Lot Number: B061529
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 86 YR