MAUDE Adverse Event Report: COVIDIEN ABRE VENOUS SELF-EXPANDING STENT SYSTEM; STENT, ILIAC VEIN

Model Number	AB9U14080090
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Perforation (2001)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Additional 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.
Event or Problem Description
A physician used an abre stent to treat a cto (chronic total occlusion-100%) in the right proximal svc of a patient.No tortuosity or calcification.12mm artery diameter.9fr terumo sheath and 260 amplatz guidewire were used.It is reported that there was damage noted to packaging and there were issues noted when removing the device from the hoop/tray, there was a small crease on the blue sheath.The rep told the physician that they didn't want to use the stent, but the damage was in the middle of the box, not where the stent was and he decided he wanted to still use it.The device prepped per the ifu, with no issues identified.The lesion was pre-dilated with a 6 balloon and then a 10 balloon.The device did not pass through a previously-deployed stent.No resistance encountered when advancing the device.No excessive force used.After post dilation of the 14 stent with a 12 balloon, the patient was bleeding internally.The team rushed in and put up a balloon for 15 mins to stop the bleeding.Then a chest tube was placed and about 2 liters of blood were removed.Said he wished he would have used a 10 balloon to post dilate instead of a 12 and that he believes the stent fractured and perfed the vessel, which caused the bleed.The stent took on a 90 degree angle.It lessened slightly after post dilation.Hcp believes stent fractured.The stent is still implanted in the patient.No attempts made to remove the stent.Patient symptoms or complications associated with this event include vessel damage/injury, perforation, haemorrhage/bleed, perfed vein - bleeding in the plural space.
Additional Manufacturer Narrative
Additional information reported that the stent is still implanted in the patient.No attempts made to remove the stent.Image review: 5 videos and 8 images were provided for evaluation.In the images/videos attached the struts are sticking out due to the tortuosity vs an actual fracture.It is unlikely that the tortuosity or the ballooning caused a fracture (12 balloon with a 14mm stent).An overinflated balloon can cause deformation or fracture at some point, but in user needs testing, a balloon had to be inflated to 26mm to deform or damage 14mm stents.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: ABRE VENOUS SELF-EXPANDING STENT SYSTEM
• Common Device Name: STENT, ILIAC VEIN
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15563318
• Report Number: 2183870-2022-00344
• Device Sequence Number: 5684940
• Product Code: QAN
• UDI-Device Identifier: 00643169796294
• UDI-Public: 00643169796294
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P200026
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/21/2022

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: 10/10/2024
• Device Model Number: AB9U14080090
• Device Catalogue Number: AB9U14080090
• Device Lot Number: B279972
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 10/07/2022
• Supplement Report FDA Received Date: 11/21/2022
• Date Device Manufactured: 10/11/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male