MAUDE Adverse Event Report: COVIDIEN PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD; STENT, SUPERFICIAL FEMORAL ARTERY

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

Patient Problems Stroke/CVA (1770); Hematoma (1884); Unspecified Infection (1930); Myocardial Infarction (1969); Neuropathy (1983); Reocclusion (1985); Pneumonia (2011); Seroma (2069); Pseudoaneurysm (2605)

Event Date 03/27/2020

Event Type  Injury  

Manufacturer Narrative

Average age.Majority gender.Event date: date of article publication.Midterm outcomes of common femoral endarterectomy combined with inflow and outflow endovascular treatment for chronic limb threatening ischaemia eur j vasc endovasc surg (2020) 59:947-955 10.1016/j.Ejvs.2020.02.028.If information is provided in the future, a supplemental report will be issued.

Event Description

This article presents a non-randomized prospective study with the aim of assessing midterm outcomes of common femoral endarterectomy combined with an inflow and outflow endovascular revascularisation procedure in patients with chronic limb threatening ischaemia (clti) over 2 years.All procedures were performed under local or regional (spinal and epidural) anaesthesia in a hybrid operating room equipped with a mobile digital angiographic system.The hybrid procedure under study was a planned one stage intervention including cfa endarterectomy as a fixed step in all cases and an inflow and/or outflow endovascular revascularisation step.159 patients (159 limbs) were included for further analysis.Included patients were subsequently divided into three groups according to the endovascular treatment zone as follows: group 1 (inflow: common and external iliac endovascular procedure); group 2 (outflow: femoropopliteal and/or infrapopliteal recanalisation); and group 3 (combined inflow and outflow treatment).The initial step was a classic cfa exposure extended to the first 3 cm of the sfa and/or profunda.Femoral endarterectomy with or without profundaplasty and patch angioplasty were performed.For subsequent endovascular procedures, the patch was punctured and the endoluminal step performed under continuous blood flow.A 6 f sheath was inserted over the wire; retrograde for inflow lesions and antegrade to complete the outflow recanalisation.In cases where inflow and outflow were both diseased, the proximal lesions were treated first.An antegrade approach via the left brachial artery was adopted if retrograde access for inflow lesions failed.Retrograde (crural) access (n = 23) using a fluoroscopically guided 21 g needle was a backup step for failed anterograde outflow recanalisations.After successful puncture, a 0.018 inch guidewire was inserted.No sheath was used through leg arteries.Crossing the lesion was achieved using a combination of non-medtronic guidewires; and 4-5 f support catheters including medtronic¿s trailblazer.Intraluminal and subintimal techniques were attempted; if they failed, the ¿double balloon¿ technique was used.Inflow lesions were managed by plain balloon angioplasty (pba) with selective bare metal stenting for chronic total occlusion (cto).Outflow lesions were treated by pba, regardless of lesion severity, and stenting was reserved for flow limiting dissections or residual stenosis >30%.Balloon and stent diameters ranged from 7 to 9 mm for inflow arteries and from 5 to 6 mm for the femoropopliteal segment, and lengths ranged from 40 to 80 mm in iliac vessels andfrom 80 to 200 mm in the outflow arteries.The balloons used were medtronic¿s admiral xtreme and the stents were either balloon expa ndable medtronic¿s visi-pro or self-expandable stents including medtronic¿s everflex self-expanding stent system.When all three leg vessels were diseased, every attempt was made to achieve at least one inline flow to the foot.The infrapopliteal artery within the tap was selected for treatment on the basis of angiosomal preference.The source artery directly supplying the target lesion was attempted first; if this failed, the least diseased indirect vessel was treated.Attempts to recanalise more than one leg vessel including the source artery were made whenever feasible in certain cases to achieve the best chances for wound healing, as indicated by the treating surgeon.Incomplete revascularisation described all cases with failed leg vessel recanalisation in groups 2 and 3, or unattempted therapy in group 1 patients.Unfractionated heparin (100 u/kg) was administered before clamping.All patients were kept on lifelong daily aspirin 100 mg plus 75 mg clopidogrel for a minimum of 30 days after the procedure.The primary outcome measure was pp, defined as freedom from clinically driven target lesion revascularisation (cdtlr) and freedom from restenosis.Secondary outcome measures were technical success, peri-operative morbidity and mortality, assisted pp, secondary patency (sp), cd-tlr; and amputation free survival (afs).The overall technical success rate was 98%.Failure was reported in three cases (and attributed to failed wire passage in severely calcified iliac vessels.A femorofemoral bypass was performed to treat the inflow lesions in these patients.Profundaplasty was performed in 29 of 34 cases with occluded profunda.The overall peri-operative complication rate was 14%.Medica lly related complications included non-fatal myocardial infarction, stroke, and pneumonia.No significant renal complications were reported.Temporary changes were detected in three patients due to contrast induced nephropathy, and serum creatinine returned to baseline within two weeks of the procedure.These complications were managed successfully with the appropriate medical treatment.There were three 30-day deaths due to myocardial infarction.Wound complications included superficial infection, seroma, and haematoma.Surgical wound drainage, debridement, or control of lymph leak were required in three patients.Standard wound care, with suitable dressings and antibiotics, were provided for these cases.Operative re-intervention was required in one patient to repair a pseudoaneurysm successfully.The mean follow up was 31.9 months.Kaplan meier analysis yielded overall primary, assisted primary, and secondary patency rates of 71.6%, 90.3%, and 96.8% ,respectively, at 24 months.Cd-tlr was deemed necessary in symptomatic cases: pba/stenting, thrombolysis, and thrombectomy followed by pba/ stenting of the target lesions to restore patency.Re-interventions increased assisted pp to 96.7% in group 1, 91.1% in group 2, and 81.9% in group 3, and sp to 100% in group 1, 95.6% in group 2, and 94.0% in group 3 at 24 months.

• Brand Name: PROTEGE EVERFLEX SELF-EXPANDING STENT SYSTEM STANDARD
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• 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 ; IE ; 091708734
• MDR Report Key: 10481705
• MDR Text Key: 205880128
• Report Number: 2183870-2020-00279
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P110023
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• 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: 08/17/2020
• 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