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

Model Number PXB35-07-37-080

Device Problems Difficult to Remove (1528); Activation, Positioning or Separation Problem (2906); Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/25/2020

Event Type  Injury  

Manufacturer Narrative

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

Event Description

Physician intended to use a 7mm visipro balloon-expandable stent system with a non-medtronic 6fr sheath and 0.035 non-medtronic guidewire during treatment of a 50mm calcified lesion in the patient¿s distal right common iliac artery.Vessel diameter reported as 7mm.Moderate vessel calcification and tortuosity are reported.Lesion exhibited 80% stenosis.No damage noted to the product packaging prior to use.No issues were noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.Pre-dilation was performed using a non-medtronic balloon.Embolic protection was not used.It is reported difficulties were encountered when removing the device prior to stent deployment.Contralateral access was used for treatment of the right common iliac.Initially an 8mm visipro was successfully placed through the 6fr sheath.The physician wanted to place a second stent distal to the first as intervention.Pre-dilation was performed, and the stent was delivered through the first stent but did not deploy.The physician then decided to place a self-expanding stent, but when an attempt was made to remove the undeployed visipro the stent was tracked through the previously deployed stent but could not be pulled back into the sheath and the stent appeared to dislodge off the balloon.The physician used a non-medtronic balloon to capture the undeployed stent and move it within the previously deployed stent where it was deployed using the 8mm balloon from the first visipro stent.The stent was not deployed in the intended area.There was no vessel damage noted.The physician then placed a 7mm everflex stent distally without issue.There were no patient complications reported and the patient procedure was completed as per their normal protocols.No injury reported.

Manufacturer Narrative

Device evaluation the visi-pro was removed from the packaging and inspected.It was observed the stent was not present on the balloon segment.The balloon showed no signs of a previously inflation.No exterior damages to the returned visi-pro were observed.Under microscope the indentations where the stent was previously loaded over the balloon was observed.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: 10500589
• MDR Text Key: 205879462
• Report Number: 2183870-2020-00284
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00643169787797
• UDI-Public: 00643169787797
• 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: 10/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/19/2023
• Device Model Number: PXB35-07-37-080
• Device Catalogue Number: PXB35-07-37-080
• Device Lot Number: B027209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2020
• Date Manufacturer Received: 10/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 90