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

Model Number PXB35-08-57-135

Device Problems Burst Container or Vessel (1074); Device Damaged by Another Device (2915); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/24/2020

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 visipro balloon expandable stent system with a non-medtronic 7fr sheath and non-medtronic guidewire during treatment of a 50mm calcified lesion in the patient¿s proximal right common iliac artery.Vessel diameter reported as 8mm moderate vessel calcification and tortuosity are reported.Lesion exhibited 99% stenosis.No damage was 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.Vessel pre-dilation was performed using a 4mm pre-dilation device.The stent is reported to have been passed through a previously deployed stent.No resistance was encountered during advancement.It is reported that stent deformation during deployment occurred.It is reported the stent became stuck on the balloon which lead to the deformation.The balloon ruptured during this.57mm of the stent is reported to have deployed in the vessel.The deformed portion of the stent was angioplastied using a 4mm balloon and a second visipro stent was placed at the area of deformation.No injury reported.

Manufacturer Narrative

Additional information: the balloon was safely removed from the patient without intervention.All components were removed.The second stent was placed at the area of deformation to correct the deformity of the first stent.There was no additional treatment required besides the implant of the 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.

Manufacturer Narrative

Image review: three photographs of cine images of the targeted vessel, (right common iliac artery), were provided for review.The images include the aortic arch and left common iliac artery.The ostium of the left common iliac artery has a previously implanted stent.A guidewire runs from the right iliac artery over the arch and into the left iliac artery.The first image is of the implanted 57mm stent fully apposed against the targeted vessel wall.Based on the condition of the stent the image is from after the stent was angioplastied using a 4mm balloon.No deformation of the stent is visible in the image.No component of the balloon expandable stent delivery system is visible with in the image.The only visible ancillary device in the image is the guidewire.The second image is of the second visi-pro balloon expandable stent implanted.A support sheath/catheter with guidewire is visible within the two visi-pro balloon expandable stents.The third image is of the two visi-pro balloon expandable stents with a guide wire running through them, over the arch, and into the left iliac artery.Product analysis: the visi-pro balloon expandable stent system was received within a sealed tyvek pouch and loosely coiled within a nested series of sealed plastic biohazard pouches.No ancillary devices were received for analysis.The visi-pro balloon chamber was received in a post-inflation profile, (e.G.Not tightly wrapped or winged), with sanguine residue within the inflation lumen and balloon chamber.The presence of sanguine residue within the inflation lumen and balloon chamber indicates communication between the inflation lumen/balloon chamber.The balloon chamber material was visually analyzed and no tears were found in the material.A 10cc water filled syringe was attached to the proximal hub luer lock and the guidewire lumen was flushed until clear fluid was observed exiting the distal tip of the delivery system.A 0.035¿ compatible guidewire was loaded with ease through the distal tip and navigated out the proximal hub with ease.A 10cc water filled syringe was attached to the inflation lumen luer lock of the y-manifold and a vacuum could be pulled and maintained.The syringe was pressurized and was met with resistance along with no inflation of the balloon chamber.A 20cc water filled syringe with manometer was attached to the inflation lumen luer lock and pressurized to 30atm.No movement of fluid into the balloon chamber was observed.The syringe with manometer was removed and a 5ml syringe was attached to the inflation lumen and a vacuum was pulled; sanguine residue tinted fluid was observed entering into the syringe under vacuum.Flushing and vacuu m of the inflation lumen through the y-manifold was done several times in attempt to remove sanguine residue from the inflation lumen.The 20cc water filled syringe with manometer was attached to the inflation lumen and pressurized to 30atm.No movement of fluid into the balloon chamber was observed.Flushing and vacuum of the inflation lumen was done again in an attempt to remove sanguine residue from the inflation lumen.The 20cc water filled syringe with manometer was attached to the inflation lumen and pressurized to 30atm.No movement of fluid into the balloon chamber was observed.It was determined that the inflation lumen is occluded with contrast and biological debris from the procedure.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: 10343309
• MDR Text Key: 201327374
• Report Number: 2183870-2020-00237
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00643169787902
• UDI-Public: 00643169787902
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/23/2023
• Device Model Number: PXB35-08-57-135
• Device Catalogue Number: PXB35-08-57-135
• Device Lot Number: B013865
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Date Manufacturer Received: 08/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 70 YR
• Patient Weight: 84