MAUDE Adverse Event Report: MEDTRONIC IRELAND COMPLETE SE IDE; STENT, SUPERFICIAL FEMORAL ARTERY

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

Patient Problems Congestive Heart Failure (1783); Embolism (1829); Hematoma (1884); Ischemia (1942); Reocclusion (1985); Shock (2072); Thrombus (2101); Stenosis (2263); Claudication (2550); Patient Problem/Medical Problem (2688)

Event Date 06/01/2018

Event Type  Injury  

Manufacturer Narrative

Age or date of birth: majority age.Sex: average sex.Journal article title: primary stenting for tasc c and d femoropopliteal lesions: one-year results from a multicentric trial on 203 patients the journal of cardiovascular surgery 2018 june; 59 (3): 392-404, doi: 10.23736/s0021-9509.16.09282-x.If information is provided in the future, a supplemental report will be issued.

Event Description

Background: recent advances in endovascular techniques have made it a seductive choice in the management of tasc c and d.Currently, this tendency remains controversial, despite high success rates.The aim of the study was to regroup and harmonize the results of three surgical teams in 5 centers in order to obtain the largest series ever published on tasc c and d femoro-popliteal lesions primary stenting.Event description: 412 patients were treated with protégé everflex and complete se with non-medtronic devices to treat the femoro-popliteal artery.The patients have a history of hypertension, dyslipidemia, bmi>30, coronary heart disease, pad, renal insufficiency, diabetes, claudication, critical limb ischemia, patients presented post procedure with minor/major amputations, reintervention, bypass surgery, in stent thrombosis, restenosis, 30 stent fracture, tlr, claudication, critical limb ischemia, distal embolization, prolonged hospital stay, hemorrhagic shock, cerebral stroke, and death 30 days post procedure 1 patient died of septic shock.30 days post procedure 1 patient died of status epilepticus.30 days post procedure 1 patient died of congestive heart failure.Methods: two hundred and three patients and 209 lower limbs were included from march 2008 to october 2013.Each patient underwent primary stenting for tasc c or d femoro-popliteal lesions.Results: mean age was 70±10; 71.4% were male with a 39.8% rate of coronary heart disease, 20.1% of renal insufficiency and 35.9% of diabetes; 57,4% suffered from claudication and 42.6% from critical limb ischemia (cli); 61.8% of the 144 limbs analyzed for run-off presented with 3 patent infra-popliteal arteries.Four hundred and three stents were implanted in the 209 limbs included.Median stented length was 252 m.Associated procedures were performed in 35 patients (17.0%) including 4.3% minor amputations.The 30-day mortality rate was 1.4% (3 patients).Major complications occurred in 19 patients (9.3%) including 7 patients (3.4%) presented with early in-stent thrombosis.Median follow- p duration was 12 months (range 9.5-17.2 months).The 12-month mortality rate was 11.8% (24 patients).The 3, 6 and 12 months primary patency rates according to kaplan meier estimates were 98.1±0.9, 85.2±2.5 and 67.0±3.3% respectively.Secondary patency rates were 9 6.1±1.9, 9.3±3.0 and 75.7±4.2% respectively.A subgroup analysis reported significantly higher patency rates for tasc c lesions compared to tasc lesions (82.1% vs.44% respectively, p=0.009).The 12-month in-stent thrombosis and restenosis rates were 19.6% and 13.9% respectively.Subgroup analysis showed higher rates of in-stent restenosis for tasc d lesions compared to tasc c lesions (35% vs.10% respectively, =0.005).The stent fracture rate was equal to 10.2% (30 stents).Occurrence of in-stent thrombosis and restenosis were associated with 3 and cases of stent fracture (type ii to iv) respectively.Freedom from tlr was 70.5%.Rutherford class decreased from 3.7 to 0.9 (3.52±1.06 to.75±1.24) (p<0.0001).At 12 months 61.3% were asymptomatic, 33.3% suffered from claudication (21.3% rutherford 1) and 5.4% suffered from cli.Healing rates were 63.9% with a limb salvage rate of 95.5% and a major amputation rate of 3.8%.Conclusions: his is the largest series of tasd.The results are encouraging with acceptable primary patency and clinical improvement at 12 months.Results from mid- to long-term follow-up are awaited.

• Brand Name: COMPLETE SE IDE
• Type of Device: STENT, SUPERFICIAL FEMORAL ARTERY
• Manufacturer (Section D): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer (Section G): MEDTRONIC IRELAND; parkmore business park west; galway
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8841532
• MDR Text Key: 152654892
• Report Number: 9612164-2019-03123
• Device Sequence Number: 1
• Product Code: NIP
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P110040
• 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
• Report Date: 07/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• 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: 07/14/2019
• 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: 70 YR