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

Model Number 24620

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

Patient Problems Occlusion (1984); Thrombosis (2100)

Event Date 04/02/2019

Event Type  Injury  

Manufacturer Narrative

Initial reporter facility address: (b)(6).

Event Description

It was reported that in-stent occlusion occurred.The subject was enrolled in the (b)(6) clinical study on (b)(6) 2016 with the patient identifier (b)(6).The index procedure was performed on the same day.The target lesion was located in the right proximal superficial femoral artery (sfa) and extended into the mid sfa with 90% stenosis.The lesion was 155mm long with a proximal reference vessel diameter of 6.0 mm and distal vessel diameter of 5.0 mm.It was classified as a tasc ii c lesion.Two eluvia study stents were implanted.The first eluvia study stent was 6mm x 120mm.The second eluvia study stent was 7mm x 60mm.On (b)(6) 2016 the subject was discharged on anti-platelet medication.On (b)(6) 2019, the subject was diagnosed with in-stent occlusion in the right sfa.No action was taken in response to the event.There were no further patient complications reported.

Manufacturer Narrative

Initial reporter facility address: (b)(6).

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the imperial clinical study on (b)(6) 2016 with the patient identifier (b)(6).The index procedure was performed on the same day.The target lesion was located in the right proximal superficial femoral artery (sfa) and extended into the mid sfa with 90% stenosis.The lesion was 155mm long with a proximal reference vessel diameter of 6.0 mm and distal vessel diameter of 5.0 mm.It was classified as a tasc ii c lesion.Two eluvia study stents were implanted.The first eluvia study stent was 6mm x 120mm.The second eluvia study stent was 7mm x 60mm.On (b)(6) 2016 the subject was discharged on anti-platelet medication.On (b)(6) 2019, the subject was diagnosed with in-stent occlusion in the right sfa.No action was taken in response to the event.There were no further patient complications reported.It was further reported that on (b)(6) 2019the subject was hospitalized for further evaluation and possible intervention.On (b)(6) 2019, 973 days post-index procedure, 100% in-stent stenosis was observed in the right proximal and mid sfa.It was treated with balloon angioplasty and there was 0% residual stenosis.On (b)(6) 2019, the event was considered resolved and the subject was discharged on the same day.No further information is available and site has been queried for the further details.

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the imperial clinical study on 11-oct-2016 with the patient identifier (b)(4).The index procedure was performed on the same day.The target lesion was located in the right proximal superficial femoral artery (sfa) and extended into the mid sfa with 90% stenosis.The lesion was 155mm long with a proximal reference vessel diameter of 6.0 mm and distal vessel diameter of 5.0 mm.It was classified as a tasc ii c lesion.Two eluvia study stents were implanted.The first eluvia study stent was 6mm x 120mm.The second eluvia study stent was 7mm x 60mm.On (b)(6) 2016 the subject was discharged on anti-platelet medication.On (b)(6) 2019, the subject was diagnosed with in-stent occlusion in the right sfa.No action was taken in response to the event.There were no further patient complications reported.It was further reported that on (b)(6) 2019 the subject was hospitalized for further evaluation and possible intervention.On (b)(6) 2019, 973 days post-index procedure, 100% in-stent stenosis was observed in the right proximal and mid sfa.It was treated with balloon angioplasty and there was 0% residual stenosis.On (b)(6) 2019, the event was considered resolved and the subject was discharged on the same day.No further information is available and site has been queried for the further details.It was further reported that on (b)(6) 2019 the subject visited the hospital for further evaluation and was subsequently hospitalized on the same day.Upon admission to the hospital, ankle brachial index (abi) was performed.It revealed an abi value of 0.50 in the right leg.On (b)(6) 2019, 974 days post-index procedure, 100% in-stent occlusion was observed in the right proximal and distal sfa.It was treated with balloon angioplasty and there was 0% residual stenosis.Per edc, baseline core lab angiography findings dated (b)(6) 2016 revealed the presence of radial stent deformation.It was further reported that on (b)(6) 2019 an angiogram was performed which revealed occlusion in the study stent placed in the right sfa.On (b)(6) 2019, ankle brachial index (abi) was performed.It revealed an abi value of 0.50 in the right leg.On (b)(6) 2019, core-lab angiography findings noted thrombus of grade 0 and absence of aneurysm.However, core lab noted the presence of isr pattern 4.No stent deformation or stent fracture was noted.

Manufacturer Narrative

Initial reporter facility address: (b)(6).

Manufacturer Narrative

Initial reporter facility address: (b)(6).

Event Description

It was reported that stent thrombosis occurred.The subject was enrolled in the imperial clinical study on 11-oct-2016 with the patient identifier (b)(6).The index procedure was performed on the same day.The target lesion was located in the right proximal superficial femoral artery (sfa) and extended into the mid sfa with 90% stenosis.The lesion was 155mm long with a proximal reference vessel diameter of 6.0 mm and distal vessel diameter of 5.0 mm.It was classified as a tasc ii c lesion.Two eluvia study stents were implanted.The first eluvia study stent was 6mm x 120mm.The second eluvia study stent was 7mm x 60mm.On (b)(6) 2016 the subject was discharged on anti-platelet medication on (b)(6) 2019, the subject was diagnosed with in-stent occlusion in the right sfa.No action was taken in response to the event.There were no further patient complications reported.It was further reported that on (b)(6) 2019 the subject was hospitalized for further evaluation and possible intervention.On (b)(6) 2019, 973 days post-index procedure, 100% in-stent stenosis was observed in the right proximal and mid sfa.It was treated with balloon angioplasty and there was 0% residual stenosis.On (b)(6) 2019, the event was considered resolved and the subject was discharged on the same day.No further information is available and site has been queried for the further details.It was further reported that on (b)(6) 2019 the subject visited the hospital for further evaluation and was subsequently hospitalized on the same day.Upon admission to the hospital, ankle brachial index (abi) was performed.It revealed an abi value of 0.50 in the right leg.On (b)(6) 2019, 974 days post-index procedure, 100% in-stent occlusion was observed in the right proximal and distal sfa.It was treated with balloon angioplasty and there was 0% residual stenosis.Per edc, baseline core lab angiography findings dated (b)(6) 2016 revealed the presence of radial stent deformation.

• Brand Name: ELUVIATM 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
• MDR Report Key: 8565531
• MDR Text Key: 143573792
• Report Number: 2134265-2019-04508
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• PMA/PMN Number: P180011
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2016
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018731616
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 53 YR