MAUDE Adverse Event Report: VERYAN MEDICAL LTD BIOMIMICS 3D VASCULAR STENT SYSTEM

Device Problems Entrapment of Device (1212); Device Dislodged or Dislocated (2923); Material Twisted/Bent (2981); Insufficient Information (3190); Activation Failure (3270)

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

Event Type  malfunction  

Manufacturer Narrative

This report is related to voluntary report number: mw5118982.The investigation in relation to this event is in progress.If veryan become aware of any additional information in relation to this event, this will be provided in a follow-up mdr supplemental report.

Event Description

This report is related to voluntary report number: mw5118982.It was identified via the maude database that a voluntary report was submitted from a risk manager at a us site in relation to a biomimics 3d vascular stent system.The report described a patient with peripheral arterial disease (pad) and long standing diabetes who presented on an unspecified date with gangrene on the distal part of the second toe on the right foot.The patient also had ulceration on the plantar aspect.She was reported as having non palpable pedal pulses and an arteriogram with intervention was offered in addition to amputation of the second toe.The vessel anatomy was described as tortuous and the stent reportedly partially deployed inside the sheath.The sheath was reported as bent, which according to the reporter's description may have contributed to the stent becoming partially dislodged.It was also reported that the aortic bifurcation angle and the partial deployment were related to a subsequent event where the stent became trapped on the wire.The patient outcome and patient problem were reported as "other" and "no clinical signs, symptoms or conditions".

Event Description

This report is related to voluntary report number: mw5118982.It was identified via the maude database that a voluntary report was submitted from a risk manager at a us site in relation to a biomimics 3d vascular stent system.The report described a patient with peripheral arterial disease (pad) and long standing diabetes who presented on an unspecified date with gangrene on the distal part of the second toe on the right foot.The patient also had ulceration on the plantar aspect.She was reported as having non palpable pedal pulses and an arteriogram with intervention was offered in addition to amputation of the second toe.The vessel anatomy was described as tortuous and the stent reportedly partially deployed inside the sheath.The sheath was reported as bent, which according to the reporter's description may have contributed to the stent becoming partially dislodged.It was also reported that the aortic bifurcation angle and the partial deployment were related to a subsequent event where the stent became trapped on the wire.The patient outcome and patient problem were reported as "other" and "no clinical signs, symptoms or conditions".The investigation has been concluded and no additional information was obtained, other than the details available on the maude database.

Manufacturer Narrative

This report is related to voluntary report number: mw5118982.The investigation was completed.The device details could not be obtained so a device history record (dhr).The details of report mw5118982, identified on 11-nov-23 were cross-referenced against all veryan complaints data to determine if this event was previously reported but the details did not match any existing information created by veryan; therefore attempts to obtain additional details were made.The following actions were carried out to obtain additional information; communication was made with veryan's us agent to check if they had received any additional information on this report.They had no other details related to this report mw5118982.The fda was contacted via the emdr@fda.Hhs.Gov email address.Veryan received a copy of the medwatch 3500a form which only reflected the details already available on maude.There were no additional details provided in the medwatch form.The category assigned was "insufficient information" and a root cause could not be determined.It could not be established if the complaint is related to a deficiency of the device.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; block 5; parkmore east business park; galway, H91 V 0TX; EI H91 V0TX
• Manufacturer Contact: alan mcdonagh ; block 5; parkmore east business park; galway, H91 V-0TX ; EI H91 V0TX
• MDR Report Key: 18281160
• MDR Text Key: 329908074
• Report Number: 3011632150-2023-00141
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 03/07/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/11/2023
• Initial Date FDA Received: 12/07/2023
• Supplement Dates Manufacturer Received: 02/09/2024
• Supplement Dates FDA Received: 03/07/2024
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 54 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White