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

Catalog Number	EVD35-08-040-080
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was intending to use an everflex entrust to treat a 20mm plaque lesion in the mid left common iliac artery.The 7mm diameter vessel had little tortuosity.A 5fr non medtronic sheath was used for the procedure.No embolic protection was used.There was no damage to the device packaging and no issues removing the device from its packaging.The device was prepped as per ifu with no issues.The lesion was predilated using a 7 x 20 device.The device passed through a previously deployed stent but no resistance was encountered and excessive force was not used.The thumbswitch/lock-pin was checked for securement prior to the procedure and the lock-pin was removed prior to deployment.It was reported that the device prematurely deployed in vivo during delivery.The red pin was pulled and a click was heard and it was noticed that the device had automatically deployed the stent.No patient injury was reported.
Additional Manufacturer Narrative
Additional information: the stent deployed at the target lesion.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: the everflex entrust stent delivery system, (sds), was received for evaluation.No ancillary devices or cine images from the procedure were received for evaluation.The entrust sds was received with the red safety tab and tube removed from the handle.Neither the red safety tab nor tube were returned for evaluation.Backlighting of the distal end of the sds catheter confirmed that the stent was deployed and the location of the distal end of the inner guidewire lumen/pusher.The distal end of the inner guidewire lumen was approximately 29mm from the distal end of sds delivery catheter.The stent is 40mm in length this indicates that the outer sheath was retracted approximately 12-14mm from its t=0 position from when it left manufacturing.The blue isolation sheath/strain relief and the grey printed strain relief were removed from the handle to allow further examination of the handle.The pull cable remains attached to the outer sheath.The sds handle was split open along it¿s seams for further examination.The pull cable appears to have been properly routed with the deployment handle.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 STANDARD
• Common Device Name: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• MDR Report Key: 8436539
• Report Number: 2183870-2019-00139
• Device Sequence Number: 1785876
• Product Code: NIP
• UDI-Device Identifier: 00821684051276
• UDI-Public: 00821684051276
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• 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): 08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/11/2021
• Device Catalogue Number: EVD35-08-040-080
• Device Lot Number: A753561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/14/2019
• Supplement Date Received by Manufacturer: 04/02/2019; 08/12/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/01/2019; 08/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR