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

Model Number 142122-02

Device Problems Failure to Advance (2524); Positioning Problem (3009)

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

Event Date 06/29/2022

Event Type  malfunction  

Manufacturer Narrative

A detailed review of the device history record associated with this lot revealed no issues that were deemed related to the issue under investigation.The investigation is in progress and any additional information received will be provided in a supplemental follow-up report.

Event Description

On (b)(6) 2022 a patient enrolled in the mimics 3d usa post market registry study was treated for two de novo lesions.The first lesion affected the sfa middle third to distal third in the right leg.A biomimics 3d (bm3d) 6.0 x 80mm stent was used to treat this lesion successfully.A contralateral approach was used and the target site was pre-dilated and post dilated with balloon angioplasty and atherectomy and drug coated balloon (dcb) angioplasty was used before the bm3d stent was implanted.The second de novo lesion required a bm3d 6 x 60mm stent placement (the subject of this report) in the more distal proximal popliteal artery in the same leg.During advancement of this device through the already placed 6 x 80mm stent, the lip of the sheath is reported by the physician to have caught a portion of the 6 x 80mm stent and disrupted (crushed) the proximal end of the stent.The bm3d 6 x 60mm delivery system was removed.A competitor bare metal stent was used to resolve the crushed proximal end of the 6 x 80mm stent and another bm3d 6 x 60mm device was advanced to the target site and deployed successfully.

Event Description

On the (b)(6) 2022, a patient enrolled in the mimics 3d usa post market registry study was treated for two de novo lesions.The first lesion affected the sfa middle third to distal third in the right leg.A biomimics 3d (bm3d) 6.0 x 80mm stent was used to treat this lesion successfully.A contralateral approach was used and the target site was pre-dilated and post dilated with balloon angioplasty and atherectomy and drug coated balloon (dcb) angioplasty was used before the bm3d stent was implanted.The second de novo lesion required a bm3d 6 x 60mm stent placement (the subject of this report) in the more distal proximal popliteal artery in the same leg.During advancement of this device through the already placed 6 x 80mm stent, the lip of the sheath is reported by the physician to have caught a portion of the 6 x 80mm stent and compressed the proximal end of the stent.The bm3d 6 x 60mm delivery system was removed.A competitor bare metal stent was used to resolve the compressed proximal end of the 6 x 80mm stent and another bm3d 6 x 60mm device was advanced to the target site and deployed successfully.

Manufacturer Narrative

A detailed review of all the lot history records pertaining to the relevant stent and delivery system lots showed no issues that were deemed related to the complaint investigation.The investigation involved: 1) communication/interviews: the complaints investigation team obtained further procedural details.A 6x80 mm biomimics 3d (bm3d) stent was placed in the sfa middle third to distal third of the right leg to treat a grade 2 calcification de novo lesion.The anatomical conditions were described as without noteworthy tortuosity or angulation.A contralateral access using a 0.014" guidewire allowed access and the lesion was pre dilated with a medtronic drug coated balloon angioplasty.No resistance was noted during device advancement or stent deployment.Further balloon angioplasty was performed by the physician post-deployment.Following the first deployment, the physician intended to implant a 6x60 mm bm3d stent more distally to treat a grade 0 calcification de novo lesion in the proximal popliteal artery.The same access approach and 0.014" guidewire was used, and again no resistance was noted during advancement.As this b3d device was being advanced through the previously implanted stent the physician made contact with the proximal portion of the implanted stent 6 x 80mm stent.The physician noted that the contact between the deployed stent and the tip/end of the outer braid of the complaint device caused a compression of the proximal portion of the stent.At this point, the physician elected to remove the complaint device,which was done so without any resistance or issues.There was no visible damage to the distal end of the complaint device after it made contact with the previously implanted bm3d stent.The physician successfully performed a balloon angioplasty and restored the compressed implanted bm3d stent.A 6x40 competitor stent was deployed in the proximal portion of the bm3d stent.There was no patient harm.A new 6x60 mm bm3d was used to treat the grade 0 calcification de novo lesion in the proximal popliteal artery.It advanced to the target site without issue and deployed successfully.2) returned device evaluation: initial observations of the delivery system found that it was returned in good condition and had its distal tip fully retracted to the distal opening of the outer braid, with a full stroke length remaining.The stent remained fully within the confines of the outer braid, and no issues could be seen with the distal tip and distal braid of the device.It was noted that the delivery system had a slight cast through the device.Also, a slight kink was found 77 mm from the distal end of the strain relief, these features are likely due to the anatomical pathway that the delivery system was tracked through.There was no damage to the distal tip, no elongation of the outer braid and all bonds were intact.The stent was deployed on a benchtop and deployed successfully.The complaint was categorised as "unable to advance" and root causes assigned were the "user" and "ancillary device".The ifu states "if a second biomimics 3d stent is required, deliver the most distal stent first to minimize the risk of stent dislodgement/damage or unsuccessful delivery of the second stent." the deployment of the distal most stent first would have eliminated all chances of making contact with a deployed stent while advancing.It is also noteworthy that a 0.014" guidewire was used in this case.The ifu states "the biomimics 3d stent is mounted on a 6f over-the-wire stent delivery system (sds) for use with a 0.035" guidewire.".

• Brand Name: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Type of Device: BIOMIMICS 3D VASCULAR STENT SYSTEM
• Manufacturer (Section D): VERYAN MEDICAL LTD; unit 11 galway technology park; parkmore road; galway city, H91 V E0H; EI H91 VE0H
• Manufacturer Contact: alan mcdonagh ; unit 11 galway technology park; parkmore road; galway city, H91 V-E0H ; EI H91 VE0H
• MDR Report Key: 15128268
• MDR Text Key: 304804188
• Report Number: 3011632150-2022-00066
• Device Sequence Number: 1
• Product Code: NIP
• UDI-Device Identifier: 05391526850398
• UDI-Public: (01)05391526850398(17)231215(11)220516(10)0000150332
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P180003
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

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
• Device Expiration Date: 12/15/2023
• Device Model Number: 142122-02
• Device Catalogue Number: 142122-02
• Device Lot Number: 0000150332
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2022
• Initial Date FDA Received: 07/29/2022
• Supplement Dates Manufacturer Received: 08/16/2022
• Supplement Dates FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2022
• 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
• Treatment: APIXABAN; ASPIRIN; CLOPIDOGREL (PLAVIX)
• Patient Outcome(s): Other
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White