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

Catalog Number	EVD35-07-080-120
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/16/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Three cine images from the procedure were obtained.The first image analyzed shows the artery prior to placement of any stents inside the distal left common iliac artery.Restrictions throughout the vessel were observed where the reported lesion was located.The second image shows the reported 7x80 stent deployed where the proximal markers are visible on the provided cine.Evidence of a restriction within the vessel proximal to the deployed stent was observed.The third image showed a second stent (8x40) deployed proximal to the first deployed stent.
Event or Problem Description
The physician used an everflex 7x80 mm self-expanding stent with entrust delivery system to treat a 60 mm moderately calcified plaque lesion in the distal-left common iliac artery.The vessel was 7 mm in diameter and was moderately tortuous.The lesion had resulted in 75% stenosis in the vessel.The procedure used a 7 fr 45 cm non-medtronic sheath and a non-medtronic guidewire.The device was prepped as per the ifu with no issues identified.The vessel was pre-dilated using a 6 mm pre-dilation device.The everflex stent did not pass through a previously deployed stent and the physician encountered no resistance delivering the device.It was reported that after deploying the stent in the target area, the physician noticed that the proximal portion of the stent was not deployed properly based on the way the end markers looked.Ivus was used to look at the inside and wall apposition.A pta balloon was easily pass ed through the stent and inflated.A new 8x40 everflex stent was deployed at the proximal portion of the first stent and the procedure was completed.No patient injury was reported.

• 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: 7031962
• Report Number: 2183870-2017-00501
• Device Sequence Number: 126825
• Product Code: NIP
• UDI-Device Identifier: 00821684051443
• UDI-Public: 00821684051443
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: P110023
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/14/2017

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: 07/29/2019
• Device Catalogue Number: EVD35-07-080-120
• Device Lot Number: A318921
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/16/2017
• Initial Report FDA Received Date: 11/14/2017
• 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: 81 YR
• Patient Weight: 44