MAUDE Adverse Event Report: MEDTRONIC IRELAND SILVERHAWK BTK; CATHETER, PERIPHERAL, ATHERECTOMY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Stenosis (2263); Vascular Dissection (3160)

Event Date 06/25/2018

Event Type  Injury  

Manufacturer Narrative

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.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, thrombosi 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 requiried 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.

• Brand Name: SILVERHAWK BTK
• Type of Device: CATHETER, PERIPHERAL, ATHERECTOMY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; ballybrit; galway,gw
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 7888679
• MDR Text Key: 120696408
• Report Number: 9612164-2018-02435
• Device Sequence Number: 1
• Product Code: MCW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061188
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• 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 Received: 09/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2018
• 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: 72 YR