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

Model Number H74939238601510

Device Problems Fracture (1260); Occlusion Within Device (1423)

Patient Problem Reocclusion (1985)

Event Date 03/26/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).It is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

The patient was enrolled in the (b)(6) clinical study.It was reported that in-stent restenosis (isr) and stent fracture occurred.On (b)(6) 2016, the index procedure was performed.The target lesion was located in the right mid superficial femoral artery (sfa) extending to the distal sfa.The target lesion was 90% stenosed, 140mm long, with a proximal reference vessel diameter of 6.00mm and distal vessel diameter of 5.00mm, and was classified as a tasc ii b lesion.The target lesion was treated with pre-dilatation and a 6x150mm eluvia stent was implanted.The target lesion was then treated with post-dilatation and residual stenosis was 5%.The patient was discharged the following day with dual antiplatelet therapy.On (b)(6) 2018, the patient presented for a protocol 24 month follow-up visit.An ultrasound revealed isr in the right sfa.An x-ray was performed which revealed grade ii multiple tine fracture on the distal part of the stent.It was reported that the stent fracture was not observed in the overlap zone.On (b)(6) 2018, the patient was hospitalized for planned intervention.On (b)(6) 2018, the right mid sfa was treated with balloon angioplasty.The ostium and proximal sfa was treated with drug coated balloon angioplasty.On (b)(6) 2018, the patient was discharged from the hospital.

• Brand Name: ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING
• Manufacturer (Section D): BOSTON SCIENTIFIC - MAPLE GROVE; one scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 7538932
• MDR Text Key: 109100085
• Report Number: 2134265-2018-04542
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: SIMILAR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2016
• Device Model Number: H74939238601510
• Device Catalogue Number: 39238-60151
• Device Lot Number: 18390231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/28/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 60 YR