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

Catalog Number 145276-12

Device Problems Fracture (1260); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 02/28/2019

Event Type  Injury  

Manufacturer Narrative

A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.The device was not returned, and the device is still implanted.An investigation will be performed.Angiography imaging will be reviewed as part of the investigation as well asa device history review.The investigation is ongoing.If further information regarding this event becomes available a follow-up report will be submitted.

Event Description

This is the same case as mdr number 3011632150-2019-00101.The patient was treated as part of the (b)(6) study on (b)(6) 2017.At index procedure ((b)(6) 2017), the patient presented with a de-novo occlusion located between the proximal third and distal third of the superficial femoral artery (sfa) of the left leg.Two biomimics 3d stents were implanted, a 6.0 x 150mm stent and a 6.0 x 125 mm stent.On (b)(6) 2019 at the patient's 24-month follow-up visit x-rays taken revealed a possible stent fracture (type ii).On the same day a reintervention for restenosis of the treated segment (target lesion) was performed.This restenosis event was previously reported as mdr submission numbers 3011632150-2019-00053 and 3011632150-2019-00054.The patient outcome is now resolved and the patient has recovered.The device remains implanted.There have been no further interventions reported for this subject since the intervention on the restenosis event.

Event Description

This mdr number is related to mdrs: 3011632150-2019-00100 and 3011632150-2019-00101 and mdr supplemental 3011632150-2019-00101_01.The patient was treated as part of the mimics-3d european post-market observational study on (b)(6) 2017.At index procedure ((b)(6) 2017), the patient presented with a de-novo occlusion located between the proximal third and distal third of the superficial femoral artery (sfa) of the left leg.Two biomimics 3d stents were implanted, a 6.0 x 150mm stent and a 6.0 x 125mm stent.On (b)(6) 2019 at the patient's 24-month follow-up visit x-rays taken revealed a possible stent fracture (type ii).On the same day a reintervention for restenosis of the treated segment (target lesion) was performed.This restenosis event was previously reported as mdr submission numbers 3011632150-2019-00053 and 3011632150-2019-00054.The patient outcome is now resolved and the patient has recovered.The device remains implanted.There have been no further interventions reported for this subject since the intervention on the restenosis event.Following completion of this investigation and review of all available angiographs, a total occlusion of both stents was confirmed.Two regions (one on each stent) were identified as having focal stent pattern distortion.In the proximally placed device (6.0 x 125mm stent) there was a focal stent distortion approximately one third from the distal edge.There was no clear separation of struts and was not considered fractured.In the distally place device (6 x 150mm) there was also a focal stent distortion approximately one quarter from the distal edge of the stent.The stent long connector elements are clearly visible and therefore this stent was not considered fractured either.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Manufacturer Narrative

This mdr number is related to mdrs: 3011632150-2019-00100 and 3011632150-2019-00101 and mdr supplemental 3011632150-2019-00101_01.A review of the device history record for this lot (#332897) did not identify any issues of manufacturing non conformance or deviations which may have been associated with this event.A complaint history review revealed one other similar complaint associated with this lot.Following review of all available angiographs the 24-month angiography confirmed a total occlusion of both stents.Two regions were identified as having focal stent pattern distortion.In the proximally placed device (6.0 x 125mm stent) there was a focal stent distortion approximately one third from the distal edge.There was no clear separation of struts and was not considered fractured.In the distally placed device (6 x 150mm) there was also a focal stent distortion approximately one quarter from the distal edge of the stent.The stent long connector elements are clearly visible and therefore this stent was not considered fractured either.In summary as the two stents implanted were placed in an overlapping configuration covering the majority of the superficial femoral artery (sfa).At the subject's 24-month follow-up visit both stents were totally occluded and re-canalised using a range of devices including cutting balloon, laser/atherectomy, drug coated balloon and stent placement.Two regions (one on each stent) were identified as having focal pattern distortion prior to any intervention.No clear strut separation was identified in either stent and it was concluded that no stent fracture occurred on either stent.The most likely root cause of the distorted stent patterns is typically as a result of deployment technique or interaction of the device with an anatomical irregularity.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL; unit 11 galway technology park; parkmore; galway city, H91 V E0H; EI H91 VE0H
• MDR Report Key: 9203153
• MDR Text Key: 175064907
• Report Number: 3011632150-2019-00100
• 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: foreign,study
• Type of Report: Initial,Followup
• Report Date: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: 145276-12
• Device Lot Number: 332897
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/20/2019
• Initial Date FDA Received: 10/17/2019
• Supplement Dates Manufacturer Received: 05/20/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: APIXABAN; ASPIRIN; CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); ENOXAPARIN-NATRIUM; ENOXAPARIN-NATRIUM
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 72 YR
• Patient Weight: 81