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

Model Number 24653

Device Problem Fracture (1260)

Patient Problems Aneurysm (1708); Pseudoaneurysm (2605)

Event Date 06/19/2020

Event Type  Injury  

Manufacturer Narrative

(b)(6).Device is a combination product.

Event Description

(b)(6) study.It was reported that the stent fractured and aneurysm occurred.The subject was enrolled in the (b)(6)study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in right distal superficial femoral artery (sfa) involving proximal popliteal artery (ppa) with 100% stenosis.The lesion was 130 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of the 7 mm x 120 mm and the 7 mm x 40 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject presented for the protocol 12 month follow-up visit.Duplex ultrasound scan on the same day revealed stent fracture of the 7 mm x 120 mm study stent with aneurysm in distal sfa of right leg.No action was taken to treat the event.At the time of reporting, the event was ongoing.

Event Description

Eminent clinical study it was reported that the stent fractured and aneurysm occurred.The subject was enrolled in the eminent clinical study on (b)(6), 2019 and the index procedure was performed on the same day.The target lesion was located in right distal superficial femoral artery (sfa) involving proximal popliteal artery (ppa) with 100% stenosis.The lesion was 130 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of the 7 mm x 120 mm and the 7 mm x 40 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6) 2019, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject presented for the protocol 12 month follow-up visit.Duplex ultrasound scan on the same day revealed stent fracture of the 7 mm x 120 mm study stent with aneurysm in distal sfa of right leg.No action was taken to treat the event.At the time of reporting, the event was ongoing.It was further reported that there was a pseudoaneurysm within the sfa due to the stent fracture.On (b)(6)2020, the subject was hospitalized for planned intervention of the target lesion.The subject underwent stent implantation with a non-bsc stent in the right distal sfa with 0% final residual stenosis.The event was considered recovered and resolved.

Manufacturer Narrative

A1: patient identifier: (b)(6) e1: initial reporter facility name: universitats herzzentrum klinik fur kardiologie und angiologie ii device is a combination product.

Manufacturer Narrative

A1: patient identifier: (b)(6) e1: initial reporter facility name: (b)(6).

Event Description

Eminent clinical study it was reported that the stent fractured and aneurysm occurred.The subject was enrolled in the eminent clinical study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in right distal superficial femoral artery (sfa) involving proximal popliteal artery (ppa) with 100% stenosis.The lesion was 130 mm long with a proximal reference vessel diameter of 6 mm and distal reference vessel diameter of 6 mm and was classified as tasc ii b lesion.The target lesion was treated with pre-dilatation and placement of the 7 mm x 120 mm and the 7 mm x 40 mm study stent.Following post dilation, residual stenosis was 0%.On (b)(6)2019, the subject was discharged on aspirin and clopidogrel.On (b)(6) 2020, the subject presented for the protocol 12 month follow-up visit.Duplex ultrasound scan on the same day revealed stent fracture of the 7 mm x 120 mm study stent with aneurysm in distal sfa of right leg.No action was taken to treat the event.At the time of reporting, the event was ongoing.It was further reported that there was a pseudoaneurysm within the sfa due to the stent fracture.On (b)(6) 2020, the subject was hospitalized for planned intervention of the target lesion.The subject underwent stent implantation with a non-bsc stent in the right distal sfa with 0% final residual stenosis.The event was considered recovered and resolved.It was further reported that on (b)(6) 2020, pre-interventional angiography revealed right common femoral artery is calcified up to the bifurcation, with 60 to 70% stenosis.Superficial femoral artery with distal stent is with approx.5 cm long pseudoaneurysm within the stented segment, starting in an area with an externally oriented stent strut, thus suspicion of a stent fracture in superficial femoral artery with-in distal stent.No constrictions were noted in popliteal artery, tibiofibular trunk, fibular artery, posterior tibial artery and the plantar artery.An 18 guide terumo j wire was passed in the popliteal artery and implantation of the 7 mm x 100 mm viabahn endoprosthesis in the distal superficial femoral artery for coverage of the pseudoaneurysm, which underwent spontaneous thrombosis after release of the endoprosthesis, following that dilation of the distal common femoral artery plus the superficial femoral artery branch with the 8 mm x 40 mm admiral in.Pact drug-coated balloon in the right distal sfa with 0% final residual stenosis.On (b)(6) 2020, the event was considered recovered and resolved and the subject was discharged on the same day.

• 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
• MDR Report Key: 10225232
• MDR Text Key: 197344193
• Report Number: 2134265-2020-08819
• 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
• Report Date: 08/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/11/2020
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023007483
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR