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

Model Number	PXB35-10-27-135
Medical Device Problem Codes	Entrapment of Device (1212); Device Damaged by Another Device (2915); Device Dislodged or Dislocated (2923); Positioning Problem (3009); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2019
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 used two visipro stents during treatment of a 50mm calcified lesion in the patient¿s right proximal common iliac artery with reported diameter 10mm.Severe vessel calcification is reported.Lesion exhibited 85% stenosis.A non-medtronic 7fr sheath and non-medtronic guidewire were used.Ifu was followed.No damage to device packaging was noted prior to use.No issues were noted when removing he visipro stents from the packaging.Lesion pre-dilation was performed using a pta balloon (7x40mm).The devices were not passed through a previously deployed stent.Resistance is reported to have been encountered when advancing.It is reported that the first stent dislodged prior to deployment and the second stent slipped off the balloon when attempting to reposition.The second stent was snared in aorta and brought to the right iliac artery and deployed.The stent was crushed using a delivery balloon.A non-medtronic covered stent was then used to cover both stents.No further injury reported.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Cine image review: the customer provided two cine images from the reported procedure.Both photos have been analyzed and could not identify a dislodged stent in either cine image.The cine images were able to identify a loaded guidewire in each.The second photo may have showed an expanded balloon within the vessel.The quality and clarity of the provided cine images could not give conclusively identify a dislodged 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.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: 9543885
• Report Number: 2183870-2020-00005
• Device Sequence Number: 2334786
• Product Code: NIO
• UDI-Device Identifier: 00643169788022
• UDI-Public: 00643169788022
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P030045
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/19/2020

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: 03/03/2022
• Device Model Number: PXB35-10-27-135
• Device Catalogue Number: PXB35-10-27-135
• Device Lot Number: A793016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 12/30/2019
• Supplement Date Received by Manufacturer: 01/07/2020; 02/18/2020
• Initial Report FDA Received Date: 01/03/2020
• Supplement Report FDA Received Date: 01/09/2020; 02/19/2020
• 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: 77 YR
• Patient Weight: 98