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

Model Number	PXB35-08-37-135
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Physician intended to use a visi pro balloon expandable stent during treatment of a plaque lesion in the patient¿s proximal common iliac artery.Moderate vessel calcification and tortuosity are reported.Lesion exhibited 80% stenosis.There was no damage noted to the product packaging prior to use.There were no issues noted when removing the device from the packaging.Ifu was followed and the device was prepped without issue.The lesion was not pre-dilated.The device was not passed through a previously deployed stent.There was no resistance encountered during advancement of the device.It is reported that stent dislodgement occurred during delivery to the lesion.The dislodged stent was removed from the patient using a snare.The procedure was then completed using a self-expanding stent.No patient injury reported.
Additional Manufacturer Narrative
Additional information: there was no vessel damage noted 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.
Additional Manufacturer Narrative
Product analysis: the visi-pro balloon expandable stent delivery system was received within a zippered closure pouch, within a sealed plastic biohazard pouch, and loosely coiled within a tied closed red plastic pouch.The dislodged and snared stent was received along with the stent delivery system.Examination of the snared stent confirmed that all components of the stent are accounted for.The snared stent exhibited stretching and elongation of stent strut rows, along with bridging stent struts between rows failure.Crimped stent witness marks were visible on the visi-pro balloon chamber material, indicating that the stent had been properly crimped to the balloon catheter.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
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 9971413
• Report Number: 2183870-2020-00114
• Device Sequence Number: 742193
• Product Code: NIO
• UDI-Device Identifier: 00643169787889
• UDI-Public: 00643169787889
• Combination Product (Y/N): N
• Initial Reporter State: SD
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/05/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2023
• Device Model Number: PXB35-08-37-135
• Device Catalogue Number: PXB35-08-37-135
• Device Lot Number: A955875
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 04/19/2020; 07/31/2020
• Initial Report FDA Received Date: 04/17/2020
• Supplement Report FDA Received Date: 04/21/2020; 08/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 83 YR
• Patient Weight: 86