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 Aneurysm (1708); Pain (1994); Obstruction/Occlusion (2422); Arteriosclerosis/ Atherosclerosis (4437); Restenosis (4576)

Event Date 02/19/2021

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(4).

Event Description

(b)(6) study.It was reported that an in-stent restenosis occurred.The subject was enrolled in the (b)(6) study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was in the right mid superficial femoral artery (sfa) and was 100% stenosed.The lesion was 40mm long with a proximal reference vessel diameter of 6.00mm and a distal reference vessel diameter of 6.00mm.It was classified as a tasc ii a lesion.Pre-dilation of the lesion was performed using a 6mm x 20mm charger balloon.Of note, after pre-dilation, a class b dissection was noted.The dissection was treated with the placement of a 7mm x 60mm eluvia stent followed by post dilation.The residual stenosis was 0%.Follow up angiography revealed no evidence of dissection.The subject was discharged with aspirin and clopidogrel.On (b)(6) 2021, the subject presented with symptoms relating to diagnosis of an in-stent restenosis in the sfa and recurrent right calf claudication.On (b)(6) 2021, the subject visited the hospital due to sudden acute pain in the right calf at rest.Duplex ultrasound was performed which showed occluded right sfa stent with reconstitution of popliteal artery via collateral and patent profunda artery.On (b)(6) 2021, the subject revisited the hospital and angiography was performed which revealed; patent infrarenal aorta with fusiform distal aortic aneurysm, patent common and external iliac arteries bilaterally and in-stent occlusion in previously placed right distal sfa and reconstitution of the above-knee right popliteal artery via multiple suprageniculate collaterals and two vessels run off via the posterior tibial and peroneal arteries.On (b)(6) 2021, 1554 days post index procedure, in response to 100% occlusion noted in the right mid sfa, revascularization was performed by heparinizing with 7500 units bolus of iv heparin with laser atherectomy.Angiography showed restored patency but a long segment in-stent restenosis of over 60%.The lesion was re-treated by placement of 7mm x 80mm absolute pro self-expanding stent across the recoil stenosis and within the stent itself.Post dilation was performed using a 6mmm x 80mm balloon.Final angiography showed wide restored patency with no evidence of recoil, dissection and/or restenosis.The residual stenosis was noted to be 0%.The event was considered resolved.There were no patient complications reported.

Manufacturer Narrative

A1.Patient identifier: (b)(6).H6.Patient codes was updated as per medical review of study indicated the aneurysm was not related to the device.

Event Description

Imperial clinical study it was reported that an in-stent restenosis occurred.The subject was enrolled in the imperial study on (b)(6) 2016 and the index procedure was performed on the same day.The target lesion was in the right mid superficial femoral artery (sfa) and was 100% stenosed.The lesion was 40mm long with a proximal reference vessel diameter of 6.00mm and a distal reference vessel diameter of 6.00mm.It was classified as a tasc ii a lesion.Pre-dilation of the lesion was performed using a 6mm x 20mm charger balloon.Of note, after pre-dilation, a class b dissection was noted.The dissection was treated with the placement of a 7mm x 60mm eluvia stent followed by post dilation.The residual stenosis was 0%.Follow up angiography revealed no evidence of dissection.The subject was discharged with aspirin and clopidogrel.On (b)(6) 2021, the subject presented with symptoms relating to diagnosis of an in-stent restenosis in the sfa and recurrent right calf claudication.On (b)(6) 2021, the subject visited the hospital due to sudden acute pain in the right calf at rest.Duplex ultrasound was performed which showed occluded right sfa stent with reconstitution of popliteal artery via collateral and patent profunda artery.On (b)(6) 2021, the subject revisited the hospital and angiography was performed which revealed; patent infrarenal aorta with fusiform distal aortic aneurysm, patent common and external iliac arteries bilaterally and in-stent occlusion in previously placed right distal sfa and reconstitution of the above-knee right popliteal artery via multiple supregeniculate collaterals and two vessels run off via the posterior tibial and peroneal arteries.On (b)(6) 2021, 1554 days post index procedure, in response to 100% occlusion noted in the right mid sfa, revascularization was performed by heparinizing with 7500 units bolus of iv heparin with laser atherectomy.Angiography showed restored patency but a long segment in-stent restenosis of over 60%.The lesion was re-treated by placement of 7mm x 80mm absolute pro self-expanding stent across the recoil stenosis and within the stent itself.Post dilation was performed using a 6mmm x 80mm balloon.Final angiography showed wide restored patency with no evidence of recoil, dissection and/or restenosis.The residual stenosis was noted to be 0%.The event was considered resolved.There were no patient complications reported.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12994406
• MDR Text Key: 282199185
• Report Number: 2134265-2021-15134
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: 24620
• Device Catalogue Number: 24620
• Device Lot Number: 0018334951
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/01/2015
• 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
• Patient Outcome(s): Other; Required Intervention; Hospitalization
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Race: White