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

Model Number EVD35-07-040-120

Device Problems Defective Device (2588); Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/19/2022

Event Type  malfunction  

Event Description

Everflex 7mm by 40mm stent came defective out of package.Red clip of the delivery system came unattached from device.Discarded the stent.No harm.

• Brand Name: EVERFLEX
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): COVIDIEN LP; 15 hampshire street; mansfield MA 02048
• MDR Report Key: 15369323
• MDR Text Key: 299372782
• Report Number: 15369323
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2022

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 Model Number: EVD35-07-040-120
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/01/2022
• Event Location: Hospital
• Date Report to Manufacturer: 09/07/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/07/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Sex: Female