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Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Embolism (1829); Thrombus (2101); Stenosis (2263)
Event Date 06/25/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4) dissection efficacy and safety of adjunctive drug-coated balloon therapy in endovascular treatment of common femoral artery disease cardiovascular revascularization medicine 10. 1016/j. Carrev. 2018. 06. Event date: date of article publication. If information is provided in the future, a supplemental report will be issued.
Event Description
Efficacy and safety of adjunctive drug-coated balloon therapy in endovascular treatment of common femoral artery disease cardiovascular revascularization medicine background: surgical endarterectomy with or without patch angioplasty has been considered the gold standard for treatment of symptomatic common femoral artery (cfa) disease. Surgical risks include wound infection, hematoma and lymph leak in approximately 17% of patients. Endovascular therapy has less procedure-related morbidity and mortality. Endovascular approaches achieve patency rates of 60% to 90% at 1 and 2 years utilizing atherectomy and balloon angioplasty. Cfa stenting has been limited due to concerns of stent kinking, thrombosis and restenosis. Combined directional atherectomy with drug-coated balloon to treat cfa disease in patients with rutherford ii/iii patients has been studied recently. We sought to study the safety and outcomes of adjunct drug-coated balloon (dcb) therapy in symptomatic cfa disease patients, including critical limb ischemia (rutherford iv), after achieving procedural success. Objective: to evaluate the additive efficacy of drug coated balloon in treating cfa disease. Methods: using retrospective single center data, we analyzed the outcomes of patients who underwent cfa interventions. In this non-randomized study, all patients from december 2010 to december 2014 with cfa disease underwent atherectomy (orbital, plaque excision or both) with adjunctive scoring balloon angioplasty (ath/pta). After december 2014, patients treated with combination atherectomy and dcb, (ath/dcb), underwent final drug delivery to the vessel wall with drug-coated balloon. Distal embolic protection devices were used in the majority of patients. Primary efficacy endpoint was 1-year primary patency and freedom from clinically driven target lesion revascularization (cd-tlr). Patency of vessels was assessed at 12-month interval using duplex ultrasound. Results: seventy de novo common femoral artery stenotic lesions were treated in both groups. Mean age was 69 in (ath/pta) group and 72 in ath/dcb group. Patients in each group had similar risk factor profiles including diabetes mellitus, hypertension, smoking, coronary artery disease, myocardial infarction, prior coronary revascularization, congestive heart failure, cerebrovascular accidents and chronic kidney disease. The ath/dcb group had more advanced disease presentation by rutherford classification (intermittent claudication in 61% and critical limb ischemia in 39% versus intermittent claudication in 76% and chronic limb ischemia in 24%) when compared with the ath/pta group. Primary efficacy endpoint was met in 85% and 94% (p
0. 26) in the ath/pta and ath/dcb groups respectively. All patients had run-off angiography at the end of procedure to ensure patency. Conclusion: adjunctive drug-coated balloon therapy does not increase the primary patency rate when compared with atherectomy and scoring balloon angioplasty alone at 1-year in common femoral artery disease treatment event description: it was reported patients in the ath/dcb received additional treatment with drug-coated balloon after achieving technical success by initial atherectomy and scoring balloon angioplasty. Atherectomy devices used included non-medtronic orbital atherectomy devices and silverhawk and hawkone excision catheters. Embolic protection devices (epd) including a non-medtronic device and spider fx were used particularly in patients with compromised run-off to decrease distal embolization. It was reported that during the index procedure, 4 vessel dissections occurred that were successfully treated with angioplasty and stenting, and an epd delivery catheter fractured in one patient during deployment at the heavily calcified subtotal occlusion of distal superficial femoral artery level in the ath/dcb group. The failed epd retrieval by endovascular techniques required retrieval by open surgery followed by surgical endarterectomy to cfa. One patient in the ath/dcb group required re-intervention within 6 months and a second patient underwent revascularization after 6 months.
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Manufacturer (Section D)
parkmore business park west
Manufacturer (Section G)
parkmore business park west
Manufacturer Contact
toni o'doherty
parkmore business park west
MDR Report Key7888870
MDR Text Key120709897
Report Number9612164-2018-02438
Device Sequence Number1
Product Code MCW
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,literatur
Reporter Occupation
Type of Report Initial
Report Date 09/19/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/22/2018
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/19/2018 Patient Sequence Number: 1