MAUDE Adverse Event Report: COVIDIEN LP EVERFLEX; STENT, SUPERFICIAL FEMORAL ARTERY

Model Number EVD35-06-150-120

Device Problems Break (1069); Activation, Positioning or Separation Problem (2906); Physical Resistance/Sticking (4012)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/05/2020

Event Type  malfunction  

Event Description

Surgeon began to deploy the everflex 6x150 stent using the manufacturer's recommended procedure.The deployment device malfunctioned and became stuck.Surgeon had to cut and break it apart in an attempt to deploy the stent.Stent deployed about 1-2cm inside the vessel.Manufacturer representative for stent contacted, unable to help in this situation.Surgeon attempted to remove stent as slowly and safely as possible.A fractured piece of stent remained in the patient.Remnant left in the distal superficial femoral artery (sfa) which was relined with s.M.A.R.T.Vascular stent system.Surgeon added: "think shorter length everflexes have worked fine, but the 6mmx150mmlength everflex has given us trouble before, especially in the setting of this type of calcified anatomy".Manufacturer response for stent, superficial femoral artery, everflex¿ self expanding peripheral stent (per site reporter).Unavailable at this time.

• Brand Name: EVERFLEX
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 10520455
• MDR Text Key: 206515278
• Report Number: 10520455
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 00821684051399
• UDI-Public: (01)00821684051399
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/09/2020

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
• Device Operator: Health Professional
• Device Model Number: EVD35-06-150-120
• Device Catalogue Number: EVD35-06-150-120
• Device Lot Number: A903059
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/09/2020
• Date Report to Manufacturer: 09/11/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 96