MAUDE Adverse Event Report: COVIDIEN UNKNOWN SE STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problems Difficult or Delayed Positioning (1157); Migration or Expulsion of Device (1395)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 06/01/2016

Event Type  Injury  

Manufacturer Narrative

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 Description

An everflex self-expanding stent was being used in an av fistula.The device was implanted into the patient.After implant it was confirmed that use by date was not identified.Device was used 2 days out of date.Used in an emergency situation.Stent was tracked through a dialysis graft to capture an unfixed ev3 self expanding stent which had jumped.Device was not removed from packaging per ifu and was not prepped per ifu.Device passed through a previously deployed stent.No resistance was experienced.There is no patient injury reported for this event.

Manufacturer Narrative

Additional information: the account felt that the stent jumped as they had used an incorrect size.

Manufacturer Narrative

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

• Brand Name: UNKNOWN SE STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth,us
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth,us
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5764933
• MDR Text Key: 48639828
• Report Number: 2183870-2016-00502
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P110023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention