MAUDE Adverse Event Report: COVIDIEN EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG; STENT, SUPERFICIAL FEMORAL ARTERY

Catalog Number EVX35-06-150-150

Device Problem Fracture (1260)

Patient Problems No Consequences Or Impact To Patient (2199); Injury (2348); Unspecified Tissue Injury (4559)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Physician intended to use an everflex entrust self-expanding stent during patient treatment.A stent fracture is reported.No patient injury reported.

Manufacturer Narrative

Updated section a - patient information, section b7- relevant history.Additional information: physician intended to use an everflex entrust self-expanding stent system to treat a heavily calcified lesion presenting 50-90% stenosis , short segment with chronic total occlusion (cto) in the arteria femoralis superficialis.The device was prepped per the instructions of use (ifu).The device passed through a previously deployed stent.Resistance was encountered during device advancement an during stent deployment.A stent fracture is reported to have occurred during deployment.Stent was deployed 1/4 , ca.40mm, when stent teared and rest of stent could not be deployed because system was blocked.¾ of stent were taken out of patient with delivery system.No attempts were made to remove the fractured stent.1/4 of stent was dilated with a pta balloon.A 6 x 58mm non-medtronic stent (smooth be stent) was used afterwards to stent the lesion.No vessel damage was noted.No further patient injury was reported.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

Cine image review two photographic images of cine images were received for evaluation.The images are of an inflated pta device within a stent fragment in the targeted vessel.The radiopaque marker hoops are visible within the images.Individual stent strut cells cannot be positively identified within the images.Since the individual stent strut cells cannot be positively identified within the images it is not possible to positively determine the length of the stent segment in the vessel based on the images provided.The length of the inflated pta device was not provided but appears to be about eight vessel diameters in length.Since the stents involved in the procedure are 6mm diameter stents the vessel diameter maybe 5mm therefore the inflated pta device maybe approximately 40mm in length.The approximate length of the stent segments appears to be approximately five vessel diameters in length, therefore approximately 25mm of stent remains in the patient.It is noted that the guidewire in the images does not appear to be a 0.035¿ compatible guidewire.Per the initial reported event description, in the first attempted stent deployment an 0.018¿ diameter guidewire was used.The entrust instruction for use provides the caution statement: using a 0.014 in (0.36 mm) or 0.018 in (0.46 mm) guidewire in a highly tortuous vessel, highly stenosed lesion, or calcified lesion could result in crossing, tracking, or deployment complications.Device evaluation the everflex stent with entrust stent delivery system, (sds), was received for evaluation.The entrust sds was received with a section of the stent exposed and the distal end of the stent exhibiting stent cell strut fractures.The sds was received loaded on a 0.018¿ compatible guidewire.The deployment handle thumbwheel could be turned, and the stent was deployed using the thumbwheel.Approximately 130mm of the 150mm length stent was received for analysis.Per the initial reported event description, a portion of the stent remained within the patient.After the stent was deployed in the lab the 0.018¿ compatible guidewire was removed from the sds.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: EVERFLEX SELF-EXPANDING PERIPHERAL STENT WITH ENTRUST DELIVERY SYSTEM LONG
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 10697098
• MDR Text Key: 212114973
• Report Number: 2183870-2020-00338
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 01/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/03/2023
• Device Catalogue Number: EVX35-06-150-150
• Device Lot Number: B003735
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2020
• Date Manufacturer Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Weight: 85