MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA CRAGG-MCNAMARA; CATHETER, CONTINUOUS FLUSH

Device Problem Insufficient Information (3190)

Patient Problem Death (1802)

Event Date 01/01/2015

Event Type  Death  

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Event Description

Event found from review of literature.Objective: thrombolysis and open surgical revascularization are current options for the treatment of acute limb ischemia (ali).Despite the several randomized controlled trials comparing the two options, no single treatment can yet be recommended as a universal initial management of ali.The purpose of this study was to evaluate contemporary endovascular and surgical revascularization for ali.Methods: consecutive patients with ali treated with endovascular revascularization (er) or open revascularization (or) between 2005 and 2011 were identified and reviewed.Procedural success and outcomes were compared between the two groups.Limb salvage and survival were assessed by time-to-event methods, including kaplan-meier estimation and competing-risks regression models.Results: a total of 154 limbs were treated in 147 patients in the er group, compared with 326 limbs in 296 patients in the or group.The mean follow-up was 14 6 18.5 months.The majority of patients presented with rutherford ii ischemia (83% for or, 90% for er).In rutherford ii patients, technical success was achieved in 90.7% of the or group vs 79.9% of the er group (p [.002), with amputation rates of 10.0% vs 7.2% (p [.35) at 30 days and 16.3% vs 13.0% (p [.37) at 1 year, respectively.In rutherford ii patients with failed bypass graft, technical success rate was 95.0% (or) vs 75.0% (er) (p [.001), whereas the amputation rate was 6.3% vs 15.38% (p [.13) at 30 days and 24.1% vs 23.1% (p [.90) at 1 year, respectively.The overall 30-day mortality rate was 13.2% (or) and 5.4% (er) (p [.012).Overall amputation rates were 13.5% (or) vs 6.5% (er) at 30 days (p [.023) and 19.6% (or) vs 13.0% (er) at 1 year (p [.074).The primary patency rate was 57% (or) and 51% (er) at 1 year (p [.74).Predictors of limb loss by life-table analysis included coronary artery disease (hazard ratio [hr], 2.0; p [.007) and rutherford category iii (hr, 19.0; p <(><<)>.001).Predictors of death by life-table analysis included age (hr, 1.03; p <(><<)>.001), end-stage renal disease (hr, 7.28; p <(><<)>.001), cancer (hr, 1.65; p [.005), and chronic obstructive pulmonary disease (hr, 1.61; p [.005).Patients for whom lysis failed and who were not candidates for bypass surgery required major amputation (10 limbs); one was treated with observation, whereas four patients (six limbs) died.Conclusions: in patients presenting with class ii ali, er or surgical or resulted in comparable limb salvage rates.Although technical success is higher with or for patients presenting with failed bypass grafts, the amputation rates are comparable.Overall mortality rates are significantly higher at 30 days and 1 year in the or group.In general, cdt was conducted with standard wire and catheter techniques to embed a multi-sidehole catheter (cragg-mcnamara; ev3 endovascular inc, (b)(4); or unifuse; angiodynamics, (b)(4)) into the thrombosed arterial segment.Thirty limbs in the er group failed thrombolysis because of inadequate response in 26 limbs (13 of them were treated with successful bypass surgery), intraoperative bleeding events in three limbs, and failure to cross the thrombosed vessel in one limb.Required major amputation (10 limbs); one was treated with observation, whereas four patients (six limbs) died.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: CRAGG-MCNAMARA
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3 NEUROVA; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5755465
• MDR Text Key: 48343058
• Report Number: 2029214-2016-00462
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K964868
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/28/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/29/2016
• 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): Death
• Patient Age: 70 YR