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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VERYAN MEDICAL LTD BIOMIMICS 3D STENT SYSTEM
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VERYAN MEDICAL LTD BIOMIMICS 3D STENT SYSTEM Back to Search Results
Catalog Number 131816-10
Device Problems Material Separation (1562); Stretched (1601); Difficult or Delayed Activation (2577)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/13/2023
Event Type  malfunction  
Manufacturer Narrative
The complaint investigation is in progress.If any additional information is provided, a supplemental report will be submitted.
 
Event Description
On (b)(6) 2023, a physician was implanting a biomimics 3d 6.0 x 100mm stent (bm3d) but there was an issue reported with the delivery system.The physician reported that all the correct steps were followed and everything was fine until the stent was half deployed.At that point it got stuck, but the physician managed to get it off the sheath.The stent was successfully implanted.The physician needed to use another stent to treat the lesion properly.The patient ended up with two stents implanted, but the overall outcome was satisfactory.The device remains implanted.
 
Manufacturer Narrative
A detailed review of all the lot history records pertaining to the relevant stent and delivery system lot showed no issues that were deemed related to the complaint investigation.Additional information regarding the procedure, patient details, as well as angiographic imaging were sought, but no additional details were provided.The delivery system was returned for evaluation.A moderate cast in the delivery system was noted as well as a kink in the proximal outer braid of the delivery system which coincided with the end of the stiff support shaft that is a part of the inner sub-assembly.A kink 160 mm from the distal edge of the outer braid was also observed.These were believed to be a result of the nature the delivery system was packaged for return.Further observations of the delivery system found that the bifurcation hub to outer braid bond had separated, confirming information that was initially reported by the site.It was seen that the distal tip of the guidewire lumen was retracted within the confines of the outer braid.The distal outer braid and its radiopaque marker were examined for the presence of damage, but none was noted.It was seen that a noteworthy amount of congealed blood was present within the distal outer braid.An attempt was made to retract the outer braid to allow for the tip to be released from the confines of the braid.This resulted in the tip being successfully released, and congealed blood was also dispelled.Slight resistance was felt while retracting the outer braid, likely due to the presence of the congealed blood, as well as the friction created between the outer diameter of the distal tip and the inner diameter of the outer braid.It is not the intention of the delivery system to have the distal tip retracted within the confines of the outer braid.The tip and the distal outer braid were examined under the microscope and noted no damage to either component.The outer braid showed elongation when measured which indicated the system was subject to a significant tensile force.The outer braid to bifurcation hub bond was the only bond that had separated, all other bonds were intact.The presence of sanding marks on the outer braid and the presence of glue in the blue bifurcating luer port indicate that the manufacturing steps were performed as intended.However, due to the limited information regarding the procedure, it cannot be fully established when the outer braid to bifurcation hub bond separated.It could have occurred during the deployment of the biomimics 3d stent, or during the handling process after the use of the device in the patient.If the bond had separated during the deployment attempt, it would suggest that a significantly high force to deploy was present during the deployment.The site noted that the delivery system became "stuck" during deployment, which was potentially in reference to the separation of the outer braid to bifurcation hub bond.Insufficient information was obtained in this investigation to determine the root cause of the difficulty in deploying the device that was reported by the physician.Without the angiographic images of the complaint procedure, it was not possible to determine the condition of the biomimics 3d stent following its deployment.The investigation was categorised as a "difficult to deploy" and a cause category could not be assigned due to insufficient information.
 
Event Description
On (b)(6) 2023, a physician was implanting a biomimics 3d 6.0 x 100mm stent (bm3d) but there was an issue reported with the delivery system.The physician reported that all the correct steps were followed and everything was fine until the stent was half deployed.At that point it got stuck, but the physician managed to get it off the sheath.The stent was successfully implanted.The physician needed to use another stent to treat the lesion properly.The patient ended up with two stents implanted, but the overall outcome was satisfactory.The device remains implanted.The delivery system was returned for evaluation.
 
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Brand Name
BIOMIMICS 3D STENT SYSTEM
Type of Device
BIOMIMICS 3D 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 Key16680369
MDR Text Key313197533
Report Number3011632150-2023-00049
Device Sequence Number1
Product Code NIP
UDI-Device Identifier05391526850077
UDI-Public(01)05391526850077(17)240122(11)220623(10)0000157842
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
P180003
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Physician
Type of Report Initial,Followup,Followup
Report Date 10/18/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/22/2024
Device Catalogue Number131816-10
Device Lot Number0000157842
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/10/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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