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

Catalog Number 131816-14

Device Problems Fracture (1260); Off-Label Use (1494)

Patient Problems Reocclusion (1985); Claudication (2550)

Event Date 07/10/2019

Event Type  Injury  

Manufacturer Narrative

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 as a device history review.The investigation is ongoing.If further information regarding this event becomes available a follow-up report will be submitted.

Event Description

The patient was treated as part of the (b)(6) post-market observational study on (b)(6) 2017.At index procedure (b)(6) 2017), the patient presented with a de-novo occlusion located in the proximal popliteal artery of the left leg.One biomimics 3d 6.0mm x 125mm stent was implanted.A restenosis of the treated vessel (target vessel) was identifed on the (b)(6) 2019.Veryan were made aware of this event on 18-september-2019.On the 20-september-2019 updated information on the event was received by veryan.The updated information included more detail on the re-intervention procedure.The reintervention ( thrombolysis therapy) took place on the (b)(6) 2019 on the segment of vessel between the distal third of the superficial femoral artery (sfa) and the distal popliteal artery.Additional information was also provided on the patient's 24-month follow-up visit which took place on (b)(6) 2019.X-rays taken revealed a possible stent fracture (type v).The patient outcome is now resolved and the patient has recovered.The device remains implanted.

Event Description

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 in the proximal popliteal artery of the left leg.One biomimics 3d 6.0mm x 125mm stent was implanted.A restenosis of the treated vessel (target vessel) was identified on the (b)(6) 2019.Veryan were made aware of this event on 18-september-2019.On the 20-september-2019 updated information on the event was received by veryan.The updated information included more detail on the re-intervention procedure.The reintervention ( thrombolysis therapy ) took place on the (b)(6) 2019 on the segment of vessel between the distal third of the superficial femoral artery (sfa) and the distal popliteal artery.Additional information was also provided on the patient's 24-month follow-up visit which took place on (b)(6) 2019.Xrays taken revealed a possible stent fracture (type v).The patient outcome is now resolved and the patient has recovered.The device remains implanted.From the angiography taken at index the stent had a normal strut pattern , although the distal edge of the stent was located below the distal cortical margin of the femur and extended to the distal edge of the p2 segment.This is outside the approved indication for use.Following completion of the investigation and review of angiographs taken at (1) 20 months post index procedure, (2) taken 22 months post index (dated (b)(6) 2019), and (3) taken on (b)(6) 2019, there appeared to be a distorted stent pattern at the level of the femoral condyle as well as a total occlusion of the stent.This occlusion was treated and follow-up imaging indicated the vessel was patent.There was an apparent distorted stent pattern but no clear strut separation was identifiable.The angiographs from (b)(6) 2019, showed stent patency but closer inspection of the distorted stent pattern revealed three discontinuities at three separate locations on the stent.This indicated a stent fracture (type 2) as classified by rocha-singh (2007) and jaff (2007).

Manufacturer Narrative

This is related to mdr number 3011632150-2019-00102.A review of the device history record for this lot did not identify any non conformances or deviations which may have been associated with this event.A complaint history review identified no other similar incidents being reported involving this lot.A review of all available angiographs provided the following information : (1) review of angiographs taken at the index procedure revealed that the stent had a normal strut pattern immediately post deployment.The distal edge of the stent was located below the distal cortical margin of the femur and extended to the distal edge of the p2 segment.This is outside the approved indication for use for this device.(2) angiographs taken 20 months post index (dated (b)(6) 2019) indicated a total occlusion of the stent and a distorted stent pattern at the level of the femoral condyle.No clear strut separation was apparent at this time but image resolution was poor.(3) angiographs taken 22 months post index (dated (b)(6) 2019) showed that at the level of the femoral condyle there also appeared to be a focal widening in the arterial lumen.This type of widening is indicative of a focal aneurysm.No clear strut separation was apparent at this time but again image resolution was poor.(4) additional angiographs provided (dated (b)(6) 2019) included digital subtraction angiographs and provided more detailed images where the stent pattern was more apparent.The pattern contained three discontinuities at three separate locations.This indicated a stent fracture (classification type ii) as per rocha-singh (2007) and jaff (2007).In conclusion the fracture was located in the distal portion of the stent and was co-located with a focal aneurysm which was not present at index procedure.The location of the fracture was at the level of the femoral condyle and this is an area which is subject to bending , axial compression and torsional physiological loading in vivo.The likely root cause of this type ii stent fracture is material fatigue of the stent due to physiological loading as well as having been placed at a location outside the approved indication for use for this device.There is no indication of a product quality issue with respect to the design, manufacturing or labelling 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; parkore; galway city, H91 V E0H; EI H91 VE0H
• MDR Report Key: 9203163
• MDR Text Key: 175062770
• Report Number: 3011632150-2019-00102
• 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

• Date FDA Received: 10/17/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: 131816-14
• Device Lot Number: 412999
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ACTILYSE 4 MG/6 STD.; ASPIRIN; CLOPIDOGREL (PLAVIX); CLOPIDOGREL (PLAVIX); HEPARIN 25000 I.U.; HEPARIN 5000 I.U.; HEPARIN 5000 I.U.; MONOEMBOLEX S.C. 3000 I.U.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 64