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 Vascular Dissection (3160); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/16/2022

Event Type  Injury  

Manufacturer Narrative

Patient identifier: (b)(6).Age at time of event: (b)(6).

Event Description

(b)(6) clinical study.It was reported that a dissection occurred.The subject underwent treatment with the eluvia drug eluting stent on (b)(6) 2022 as a part of the (b)(6) clinical trial.The target lesion was in the left mid superficial femoral artery (sfa) with proximal reference vessel diameter of 6.5 mm and distal reference vessel diameter of 5.0 mm with lesion length of 115 mm and 90 % stenosis and classified ass tasc ii c lesion.Prior to target lesion treatment, pre dilation was performed using 5 mm x 120 mm non-bsc pta balloon.Treatment of target lesion was performed with placement of study device, an eluvia drug eluting stent of 6 mm x 120 mm.Following post dilation with 5 mm x 120 mm non-bsc-18 pta balloon, the final residual stenosis was noted be 0%.On (b)(6) 2022, on the same day of index procedure, during or after treatment of target lesion #001, dissection of grade c was noted.In response to the event, bailout stent was implanted.Following post dilation with 5 mm x 120 mm non-bsc pta balloon, the final residual stenosis was noted be 0%.The complication was resolved and on (b)(6) 2022, the subject was discharged from the hospital.

Manufacturer Narrative

A1 - patient identifier: (b)(6).A2 - age at time of event: 74 years.

Event Description

Elegance clinical study.It was reported that a dissection occurred.The subject underwent treatment with the eluvia drug eluting stent on (b)(6) 2022 as a part of the elegance clinical trial.The target lesion was in the left mid superficial femoral artery (sfa) with proximal reference vessel diameter of 6.5 mm and distal reference vessel diameter of 5.0 mm with lesion length of 115 mm and 90 % stenosis and classified ass tasc ii c lesion.Prior to target lesion treatment, pre dilation was performed using 5 mm x 120 mm non-bsc pta balloon.Treatment of target lesion was performed with placement of study device, an eluvia drug eluting stent of 6 mm x 120 mm.Following post dilation with 5 mm x 120 mm non-bsc-18 pta balloon, the final residual stenosis was noted be 0%.On (b)(6) 2022, on the same day of index procedure, during or after treatment of target lesion #001, dissection of grade c was noted.In response to the event, bailout stent was implanted.Following post dilation with 5 mm x 120 mm non-bsc pta balloon, the final residual stenosis was noted be 0%.The complication was resolved and on (b)(6) 2022, the subject was discharged from the hospital.It was further reported that during the treatment of target lesion, dissection of grade c was noted after the angioplasty with the non-bsc pta balloon.In response to the event, a bailout stent was implanted.Following post dilation with 5 mm x 120 mm passeo-18 pta balloon, the final residual stenosis was noted be 0%.As the dissection occurred prior to use of the study stent, the event is not related to the bsc device.

• 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 ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14161476
• MDR Text Key: 289673823
• Report Number: 2134265-2022-04322
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): Y
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Study,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2023
• Device Model Number: 24653
• Device Catalogue Number: 24653
• Device Lot Number: 0027063299
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Race: Asian