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

Model Number PXB35-08-37-135

Device Problems Burst Container or Vessel (1074); Premature Activation (1484); Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

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 with a non-medtronic 6fr sheath during treatment of a 37mm calcified lesion in the patient¿s proximal right common iliac artery of reported diameter 7mm.Sever vessel calcification is reported.Lesion exhibited 50% 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.An inflation device was used for balloon inflation.Pre-dilation was performed using 2.0 and 4.0 pta balloons.The device was not passed through a previously deployed stent and no resistance was encountered during advancement.Issues are reported during stent deployment.It is reported at an inflation pressure of 10atm on first inflation a circumferential/radial balloon burst occurred leading to partial deployment of the proximal tip of the stent.When removed, it was observed a small portion of the balloon had detached on the wire.The radiopaque marker was also observed on the wire.The stent was then fully expanded using a coronary balloon followed by a peripheral balloon.The patient is reported to have remained stable throughout the procedure and post procedure.The bilateral iliac stents remained intact and open post-procedure.No patient injury reported.

Manufacturer Narrative

Additional information: no detached fragments remained in the patient.No vessel damage was noted by the physician and final images confirmed under fluoroscopy.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.

Manufacturer Narrative

Product analysis #703787187:eight procedural images were received of the visi-pro balloon-expandable peripheral stent system.Four photographs of cine images, three photographs of the device, and one image of the shelf carton.The first image is of the visi-pro being implanted in the patient¿s proximal right common iliac artery.The proximal end of the stent is starting to deploy.No deployment flaring of the distal end of the stent is evident in the image.No radiopaque contrast solution is visible in the balloon.The visi-pro radiopaque marker bands are visible in the image.The image was most likely taken shortly after the balloon burst.The second image is a wide-angle view of the stent visi-pro being implanted in the patient¿s proximal right common iliac artery.The proximal end of the stent is starting to deploy.No deployment flaring of the distal end of the stent is evident in the image.The visi-pro system radiopaque marker bands are not visible in the image.The image was most likely taken after the visi-pro system was removed from the patient.The third image is a close-up photograph of the remaining balloon chamber.The remnant of the balloon chamber exhibits a radial tear of the balloon chamber material.Sanguine residue is on and or within the balloon chamber.The fourth image is of the inner guidewire lumen and proximal end of the balloon chamber.The balloon¿s proximal radiopaque marker band is present on the inner guidewire lumen.The distal end of the inner guidewire ends with a witness mark of the distal radiopaque marker band.The distal radiopaque marker band, distal balloon bond, and distal tip are not in the image.The fifth image is of the guidewire used in the procedure and the visi-pro distal radiopaque marker band on the guidewire.Neither distal inner guidewire lumen material, distal balloon chamber material, nor distal tip are in the image.Therefore, not all components of the visi-pro system are accounted for.The sixth image is of the visi-pro shelf carton and includes a sticker of patient information.The seventh image is a procedural image of the guidewire running through the targeted vessel anatomy, (the patient¿s proximal right common iliac artery).Measurements of the targeted vessel anatomy is annotated on the image.The eighth image is of the results of the procedure.The visi-pro stent has been implanted at the targeted vessel anatomy.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

Additional information: the balloon in the right iliac was unable to be removed and the sheath was pulled with the balloon.Manual pressure was applied.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.

• 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: 10137278
• MDR Text Key: 194605392
• Report Number: 2183870-2020-00169
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 00643169787889
• UDI-Public: 00643169787889
• 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,Followup,Followup
• Report Date: 10/22/2020

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: 03/04/2022
• Device Model Number: PXB35-08-37-135
• Device Catalogue Number: PXB35-08-37-135
• Device Lot Number: A793444
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/04/2020
• Initial Date FDA Received: 06/10/2020
• Supplement Dates Manufacturer Received: 06/16/2020; 06/19/2020; 09/25/2020; 07/14/2020
• Supplement Dates FDA Received: 06/18/2020; 06/22/2020; 09/28/2020; 10/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR