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 Problems Reocclusion (1985); Claudication (2550)

Event Date 08/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(6).(b)(4).Device is a combination product.Device evaluated by mfr: 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

(b)(6).It was reported that the stent was fractured.In (b)(6) 2016, the patient presented under category 3 as per rutherford assessment.The target lesion was located in the left leg mid and distal superficial femoral artery (sfa) with 100% stenosis and was 120 mm long with a proximal reference vessel diameter of 4.00 mm and distal vessel diameter of 6.00 mm and was classified as tasc ii b lesion.On (b)(6) 2016, the lesion was treated with pre-dilatation and placement of a 6.0 x 150 mm study stent.Following post-dilatation, residual stenosis was 0%.The patient was discharged the next day on antiplatelet therapy.In (b)(6) 2017, the patient was noted with stent occlusion in the left sfa.On (b)(6) 2017, during 12 month follow up visit, the patient underwent duplex ultrasound (dus) which revealed the following.Within the common femoral artery (cfa), the proximal waveforms were noted to be bi-triphasic, compitable with good patency of the stent in the left common iliac artery.Within the sfa, the proximal segment of the superficial femoral artery was of a small caliber but was patent.There was an occlusion of the stent noted in the mid and distal segments of the left sfa.Within the popliteal artery, the waveforms were noted to be biphasic in the popliteal region and distally.Left ankle-brachial index was measured at 0.76, which was significantly reduced compared to the previous dus.During the 12 month follow up, dus core lab finding noted in stent stenosis category as "total occlusion of the target lesion".X-ray core lab finding dated (b)(6) 2017, noted grade 0- "no strut fracture" for the study stent.On (b)(6) 2017, the patient was noted with occlusion of the stent in the mid and distal segments of the left sfa.However, no action was taken at that point of time.On (b)(6) 2017, the patient was admitted to the hospital for scheduled arteriography due to stage ii b claudication in the left lower leg and occlusion of stent in the left sfa.On (b)(6) 2017, arteriography of left lower limb revealed the following.Mild stenosis with adequate opacification in the deep artery of the cfa.A partly occluded proximal sfa, followed by lesion length of 25 cm significant occlusion in the mid and distal region of stented sfa.There was a collateral circulation at the end of the stent.A slightly infiltrated proximal segment and normal triple-vessel distal vascular bed of the popliteal artery.Follow-up core-lab angiography finding dated (b)(6) 2017, noted grade 0 thrombus, absence of aneurysm and presence of in stent restenosis (isr) pattern 4 in the left mid sfa.Additionally, stent fracture was noted.On (b)(6) 2017, 420 days post index procedure, the 100% occlusion noted at entire sfa was treated with balloon angioplasty with 0% residual stenosis.The event was considered resolved and the subject was discharged on the same day.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that on (b)(6) 2017, the subject presented to the study hospital for 12 month follow up visit and stated that he had been experiencing the claudication for two months (since (b)(6) 2017).Follow-up core-lab angiography finding dated 22-nov-2017 found no stent fracture.

• 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: 7111269
• MDR Text Key: 94629964
• Report Number: 2134265-2017-12503
• Device Sequence Number: 1
• Product Code: NIU
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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,Followup
• Report Date: 11/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2017
• Device Model Number: H74939238601510
• Device Catalogue Number: 39238-60151
• Device Lot Number: 18822231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/23/2017
• Initial Date FDA Received: 12/12/2017
• Supplement Dates Manufacturer Received: 12/27/2017
• Supplement Dates FDA Received: 01/09/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2016
• 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): Required Intervention
• Patient Age: 51 YR