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 06/21/2022

Event Type  Injury  

Event Description

Eminent clinical study.It was reported that the stent broke and an in stent aneurysm occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) with 100% stenosis and was 116 mm long with a proximal reference vessel diameter of 4.4 mm and distal reference vessel diameter of 5.2 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation, followed by the placement of the 6 mm x 120 mm study stent.Post dilatation was performed with final residual stenosis of 0%.On (b)(6) 2019, venous bleeding at puncture site occurred.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2022, 917 days post index procedure, the subject was diagnosed with presence of aneurysm in the stent after a broken stent.On (b)(6) 2022, the subject was hospitalized for further treatment and evaluation.Subject underwent an interventional procedure by implanting a stent graft, as a treatment for the event.The event was considered resolved.

Manufacturer Narrative

Age at time of event: patient was 78 years old at the time of study enrollment in 2019.

Manufacturer Narrative

A2.Age at time of event: patient was 78 years old at the time of study enrollment in 2019.H6: patient codes: updated from aneurysm to pseudoaneurysm.B7: other relevant history: additional information b5: describe event or problem: additional information.

Event Description

Eminent clinical study it was reported that the stent broke and an in stent aneurysm occurred.The subject was enrolled in the eminent study on (b)(6) 2019 and the index procedure was performed on the same day.The target lesion was located in the right distal superficial femoral artery (sfa) with 100% stenosis and was 116 mm long with a proximal reference vessel diameter of 4.4 mm and distal reference vessel diameter of 5.2 mm and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation, followed by the placement of the 6 mm x 120 mm study stent.Post dilatation was performed with final residual stenosis of 0%.On (b)(6) 2019, the subject was discharged with antiplatelet therapy.On (b)(6) 2019, venous bleeding at puncture site occurred.On (b)(6) 2022, 917 days post index procedure, the subject was diagnosed with presence of aneurysm in the stent after a broken stent.On (b)(6) 2022, the subject was hospitalized for further treatment and evaluation.Subject underwent an interventional procedure by implantation of a stent graft as a treatment for the event.On (b)(6)2022, the event was considered as resolved.It was further reported that on (b)(6)2021, 731 days post index procedure, the subject presented for protocol scheduled 24 months follow up visit.On arrival, rutherford category was 0 (asymptomatic).Ankle brachial index was 0.79.On the same day, doppler ultrasound revealed triphasic flow curve with steep acceleration along the entire superficial femoral artery and the stent appeared ruptured in the distal third.Moreover, on-perfused to-circular halo along the indwelling stent with a diameter of up to 5.5 mm was seen.On (b)(6)2021, x -ray findings of right thigh revealed the stent fracture at the distal third of the stent at the femoropopliteal junction.On (b)(6) 2022, 917 days post index procedure, color doppler ultrasound of right femoral artery showed no relevant stenosis due to moderate atherosclerotic changes in the proximal and middle third, indwelling stent in the distal third of the sfa and significant stent fracture was seen with significant dislocation of the distal stent fragment in the lower third of the stent.The distal fragment was displaced nearly 8 mm from the proximal fragment.The aneurysmal expansion was observed 17 mm in diameter and 6 cm in longitudinal extension around the stent fracture site in the sfa.Doppler sonography showed marked turbulence between fragments, but both the proximal and distal stent fragments were perfused.Based on the diagnostic findings, the subject was diagnosed with pseudoaneurysma instent at broken stent.On (b)(6) 2022, the event (002) was considered as recovered/resolved.On (b)(6) 2022, the subject was discharged in a stable condition with the advice of antiplatelet medication.

• 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: 15337129
• MDR Text Key: 299078768
• Report Number: 2124215-2022-33482
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: AU
• 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
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/07/2021
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0023848277
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/12/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Sex: Male
• Patient Race: White