MAUDE Adverse Event Report: VERYAN MEDICAL VERYAN BIOMIMICS STENT; STENT, SUPERFICIAL FEMORAL ARTERY

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981); Activation Failure (3270)

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

Event Type  malfunction  

Event Description

Patient with peripheral arterial disease and long-standing diabetes.She presented with gangrene of the distal toe on the right second toe with ulceration on the plantar aspect.She has nonpalpable pedal pulses so arteriogram with intervention was offered in addition to the second toe amputation.Torturous vessel, stent partially deployed inside sheath, but sheath was bent which could have contributed to the stent becoming partially dislodged.Aortic angle of aortic bifurcation and partial deployment related to stent being trapped on wire.

Event Description

Additional information received for report mw5118982 on 01/02/202 to update reporter information.

• Brand Name: VERYAN BIOMIMICS STENT
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): VERYAN MEDICAL
• MDR Report Key: 17229421
• MDR Text Key: 318242639
• Report Number: MW5118982
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White