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

Catalog Number EVD35-06-150-150

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 07/08/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Physician used an everflex entrust with a 5/6fr radial sheath and 0.035 guidewire during treatment of a calcified lesion within the patient¿s id superficial femoral artery (sfa).Moderate tortuosity and severe calcification are reported.Ifu was followed.Device prepped without issue.Pre-dilation was performed.Difficulty was experienced when trying to cross.It is reported stent deformation during positioning occurred.The stent is reported to have partially deployed and an audible click was heard.The stent then stopped deploying even while cranking the thumb roller.The red safety device was attempted to be removed and reinserted.Eventually the delivery device was pulled back and the stent snapped.Excessive force was used.Device was removed leaving the deployed portion in the patient.Prolonged balloon inflation was performed to complete the procedure.

Manufacturer Narrative

Image review: the customer provided a photo of distal end of the deployment system.The distal tip of the catheter showed portions of the stent stretched out distally from the distal rim of the catheter shaft placed over a white piece of gauze.Product analysis: the everflex entrust was retuned for evaluation.The everflex entrust was inspected and observed the red pull cable was removed from the handle assembly.Approximately 0.3cm of the stent was protruding out from the distal tip of the catheter shaft.The exposed stent was fractured.The tantalum markers on the distal end of the stent were fractured off from the stent.With direct light applied to the distal end of the catheter, approximately 11 cm of the stent remained loaded.Approximately 4cm of the stent fractured off from the deployment system.No bends to the catheter shaft was observed.It was noted a black wire/string was visible from the inside of the handle assembly and was sticking out from the area of the thumb wheel.The thumb wheel was rotated with no resistance.There was no further deployment of the stent.The handle assembly was cracked opened and observed the pull cable was detached from the silver outer.The end of the pull cable wire was frayed.The proximal area of the silver outer was inspected and observed the previously location where the pull cable was attached.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 physician was pleased with the results post balloon inflation.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: 8788703
• MDR Text Key: 150972670
• Report Number: 2183870-2019-00369
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051634
• UDI-Public: 00821684051634
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 10/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/20/2022
• Device Catalogue Number: EVD35-06-150-150
• Device Lot Number: A802141
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Date Manufacturer Received: 10/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 72 YR