MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM; STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING

Model Number 24653

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Pain (1994); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437)

Event Date 10/22/2021

Event Type  Injury  

Event Description

It was reported that stent occlusion occurred.The subject was enrolled in (b)(6) on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in the left proximal superficial femoral artery (sfa) with 70% stenosis and was 150 mm long with a proximal reference vessel diameter of 5.3 mm and was classified as tasc ii c lesion.Target lesion was treated with direct placement of two study stents; 6mm x 120mm and 6mm x 80mm.Post dilatation was not performed and residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet medication.On (b)(6) 2021, 1030 days post index procedure, the subject presented with unknown symptoms and was diagnosed with thrombotic occlusion in the sfa.On (b)(6) 2021, subject seen in the clinic for a check up and complained that pain in the left is more than right.An angio ct was performed on the same day which revealed the superficial femoral artery on the left occluded.Upon consultation, the subject was recommended to undergo surgical intervention as a treatment for the event.On (b)(6) 2021, the subject was hospitalized for further treatment and evaluation.On (b)(6) 2021, the target lesion was treated by performing fp1 bypass surgery.Arteriotomy was performed and good back flow was noted.Then end-to-side anastomosis of the graft on the artery.Later endarterectomy was performed which resulted in good quality of posterior wall and a short arteriotomy.Post procedure, hemostasis is achieved, and no complications were noted.The event was considered as recovered/ resolved.On (b)(6) 2021, the subject was discharged.

Manufacturer Narrative

Patient identifier: (b)(6).

Manufacturer Narrative

A1: patient identifier: (b)(6).

Event Description

It was reported that stent occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in the left proximal superficial femoral artery (sfa) with 70% stenosis and was 150 mm long with a proximal reference vessel diameter of 5.3 mm and was classified as tasc ii c lesion.Target lesion was treated with direct placement of two study stents; 6mm x 120mm and 6mm x 80mm.Post dilatation was not performed and residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet medication.On (b)(6) 2021, 1030 days post index procedure, the subject presented with unknown symptoms and was diagnosed with thrombotic occlusion in the sfa.On (b)(6) 2021, subject seen in the clinic for a check up and complained that pain in the left is more than right.An angio ct was performed on the same day which revealed the superficial femoral artery on the left occluded.Upon consultation, the subject was recommended to undergo surgical intervention as a treatment for the event.On (b)(6) 2021, the subject was hospitalized for further treatment and evaluation.On (b)(6) 2021, the target lesion was treated by performing fp1 bypass surgery.Arteriotomy was performed and good back flow was noted.Then end-to-side anastomosis of the graft on the artery.Later, endarterectomy was performed which resulted in good quality of posterior wall and a short arteriotomy.Post procedure, hemostasis was achieved, and no complications were noted.The event was considered as recovered/ resolved.On (b)(6) 2021, the subject was discharged.It was further reported that on (b)(6) 2021, 1038 days post index procedure, the subject presented with claudication and pain at rest.An angio ct was performed on both limbs which revealed a left post-ostial occlusion of the superficial femoral artery.On (b)(6)2021, the target lesion was treated by performing fp1 bypass surgery using a non-boston scientific 6 mm vascular prosthesis, sub sartorial tunneling of the graft in the upper leg and by exposing the common femoral artery, the external iliac artery and distal exposure of the deep femoral artery to past the bone and the superficial femoral artery.The graft on the distal segment p1 was clamped on the proximal and the distal side with vessel loops.Then end-to-side anastomosis of the graft on the artery with a non-boston scientific suture.The end of the posterior wall is smooth.On (b)(6) 2021, the subject was discharged in stable condition.

Event Description

It was reported that stent occlusion occurred.The subject was enrolled in the eminent study on (b)(6) 2018 and the index procedure was performed on the same day.Target lesion was located in the left proximal superficial femoral artery (sfa) with 70% stenosis and was 150 mm long with a proximal reference vessel diameter of 5.3 mm and was classified as tasc ii c lesion.Target lesion was treated with direct placement of two study stents; 6mm x 120mm and 6mm x 80mm.Post dilatation was not performed and residual stenosis was 0%.On (b)(6) 2018, the subject was discharged with antiplatelet medication.On (b)(6) 2021, 1030 days post index procedure, the subject presented with unknown symptoms and was diagnosed with thrombotic occlusion in the sfa.On (b)(6) 2021, subject seen in the clinic for a check up and complained that pain in the left is more than right.An angio ct was performed on the same day which revealed the superficial femoral artery on the left occluded.Upon consultation, the subject was recommended to undergo surgical intervention as a treatment for the event.On (b)(6) 2021, the subject was hospitalized for further treatment and evaluation.On (b)(6) 2021, the target lesion was treated by performing fp1 bypass surgery.Arteriotomy was performed and good back flow was noted.Then end-to-side anastomosis of the graft on the artery.Later, endarterectomy was performed which resulted in good quality of posterior wall and a short arteriotomy.Post procedure, hemostasis was achieved, and no complications were noted.The event was considered as recovered/ resolved.On (b)(6) 2021, the subject was discharged.It was further reported that on (b)(6) 2021, 1038 days post index procedure, the subject presented with claudication and pain at rest.An angio ct was performed on both limbs which revealed a left post-ostial occlusion of the superficial femoral artery.On (b)(6) 2021, the target lesion was treated by performing fp1 bypass surgery using a non-boston scientific 6 mm vascular prosthesis, sub sartorial tunneling of the graft in the upper leg and by exposing the common femoral artery, the external iliac artery and distal exposure of the deep femoral artery to past the bone and the superficial femoral artery.The graft on the distal segment p1 was clamped on the proximal and the distal side with vessel loops.Then end-to-side anastomosis of the graft on the artery with a non-boston scientific suture.The end of the posterior wall is smooth.On (b)(6) 2021, the subject was discharged in stable condition.It was again further reported that on (b)(6) 2021, 24 month patency analysis examination revealed 50-99% instent stenosis with absolute psv stenosis category and left common femoral stenosis was noted which was proximal to stent.The subject was suggested to start/continue intensive walking training however, the subject denied doing the same and alternative treatment was requested to get rid of the pain as soon as possible.Further information from 27-oct-2021, clarified that the bypass was performed on the femoral popliteal pi artery was constructed on the left.Arteriotomy of the common femoral artery was performed where, moderate-grade stenosis was noted.Post procedure, there were no complications and the recovery was smooth.

Manufacturer Narrative

A1 - patient identifier - (b)(6).

• Brand Name: ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 13877807
• MDR Text Key: 287835964
• Report Number: 2134265-2022-02374
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/08/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0022405181
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/24/2022
• Supplement Dates Manufacturer Received: 03/24/2022; 09/05/2022
• Supplement Dates FDA Received: 04/21/2022; 09/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/12/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Race: White