MAUDE Adverse Event Report: COVIDIEN SPIDER FX; DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC

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

Patient Problems Embolism (1829); Hematoma (1884); Reocclusion (1985); Perforation (2001); Vascular Dissection (3160)

Event Date 04/01/2019

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: majority age.Sex: majority gender.Date of event - published date.(b)(4).Title: "optical coherence tomography guided directional atherectomy with antirestenotic therapy for femoropopliteal arterial disease." source: journal of cardiovascular surgery [0021-9509], stavroulakis, konstantinos, yr: 2019, vol: 60, iss: 2, pg: 191 -197.If information is provided in the future, a supplemental report will be issued.

Event Description

The aim of this study was to evaluate the performance of optical coherence tomography (oct)-guided directional atherectomy with anti restenotic therapy (daart) in the treatment of femoropopliteal atherosclerosis.The aim of atherectomy (non-medtronic device) was to reduce the plaque burden at least 50%, while the procedure goal was to achieve a 30% residual stenosis by visual estimation.Thirty-three patients met the inclusion criteria and were included into this study.The primary measure outcome of this study was primary patency, defined as freedom from significant restenosis or occlusion without any reintervention based on duplex ultrasound evaluation.Secondary outcomes were technical success rate (tsr), secondary patency rate (spr) and freedom from clinical driven target related revascularization (tlr).Technical success was defined as residual stenosis.In patients with intention to treat a 7 or 8 f arterial sheath was introduced.After successful recanalization of the target lesion, oct was applied to identify plaque location, orient the cutter and estimate the debulking depth.Adjunctive dcb angioplasty was applied in all cases.The dcb was inflated to a nominal diameter with complete lesion coverage from ¿healthy to healthy.¿ the inflation time was 180 seconds.Flow-limiting dissections after daart were treated by a prolonged angioplasty with an uncoated balloon.Bailout stenting was indicated only in cases of persistent flow limiting dissections after prolonged vessel dilation.The dcb selection was left at the discretion of the treating interventionist.All procedures were performed with a spider fx distal protection device.The distal protection device was sized slightly larger than the vessel diameter.The in.Pact admiral/pacific dcb catheter (medtronic) was used in the treatment of 73% of lesions.Remaining were treated with a non-medtronic dcb.A single target vessel perforation and 2 peripheral embolizations were observed.Both embolizations were successfully treated by endovascular aspiration.A severe calcified tasc ii d sfa lesion required a bailout stent deployment resulting in a bailout stent rate of 3%.Although the final angiography did not reveal any major dissection, a non-flow limiting dissection was observed in 11 lesions after daart (30%).The access site complications included 5 hematomas, which did not require surgical treatment and a post procedural stenosis of the access vessel.The last patient was treated with poba of the access site.The median follow-up time was 15 months.The primary patency rate at 12 and 18 months was 93% and 78% respectively.The 12- and 18-month secondary patency rate was 95%.The freedom from target lesion revascularization amounted to 100% at 12 months and 84% at 18 months.Among the reinterventions performed, 3 lesions were treated with daart, one patient with a single drug eluting stent and the final lesion with a bare metal stent placement (everflex, medtronic).In the clinical setting the majority of the patients were asymptomatic and no major amputation was performed.The 12- and 18-month survival rate was 94% and 89% respectively.

• Brand Name: SPIDER FX
• Type of Device: DEVICE, CORONARY SAPHENOUS VEIN BYPASS GRAFT, TEMPORARY, FOR EMBOLIZATION PROTEC
• Manufacturer (Section D): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): COVIDIEN; 4600 nathan lane north; plymouth MN 55442
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8518916
• MDR Text Key: 142205321
• Report Number: 2183870-2019-00175
• Device Sequence Number: 1
• Product Code: NFA
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• 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: 04/02/2019
• 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: 67 YR