MAUDE Adverse Event Report: MEDTRONIC MEXICO ADMIRAL XTREME; CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL

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

Patient Problems Hemoptysis (1887); Pulmonary Edema (2020); Perforation of Vessels (2135); Rupture (2208); Stenosis (2263)

Event Date 08/27/2018

Event Type  Injury  

Manufacturer Narrative

Event date: date of article publication acquired pulmonary vein stenosis after radiofrequency ablation for atrial fibrillation: single-center experience in catheter interventional treatment jacc: cardiovascular interventions (2018) vol 11, issue 16; 626-32 10.1016/j.Jcin.2018.05.016.If information is provided in the future, a supplemental report will be issued.

Event Description

Objectives: the aim of the study was to analyse and report a single-center experience with catheter interventional treatment of radiofrequency-i nduced pulmonary vein stenosis (pvs) following atrial fibrillation (af) ablation.Catheter interventional treatment of radiofrequency-induced pvs following af ablation remains a challenging field because of a lack of randomized data and treatment guidelines.Methods: from january 2004 to september 2017, a total of 11,103 ablation procedures with pvi (pulmonary vein isolation) were performed at our institution, consisting of 10,971 catheter interventional rfas (radio frequency ablations) and cryoballoon ablations, 115 intraoperative rfas, and 17 hybrid pvi procedures as a combination of catheter interventional endocardial and surgical epicardial ablation.60% of patients were male, with an average age of 62 years.The total pvs rate for ablation of af was 0.78% (87 of 11,103) and 0.74% (81 of 10,971) if surgical cases were excluded.Thirty-nine of 105 patients (37%) with pvs were treated with a total of 84 catheter interventional procedures.Pta and stent implantation procedures were performed under deep propofol sedation.For vascular access, 2 femoral venous sheaths (11 and 8 f) and a 4-f arterial sheath for invasive rr-interval monitoring were used.After transseptal puncture, a non-mdt steerable sheath was introduced into the left atrium.A 5-f multipurpose catheter was advanced over a 0.035-inch guidewire to the ostium of the affected pv.Intubation of pv (pulmonary vein) and crossing of stenosis was supported by different guidewires depending on the degree of stenosis and the operator¿s discretion.Balloon venoplasty was done by positioning an appropriately sized balloon at the point of maximal stenosis and inflating to a median pressure of 10 atm for 30 to 60 s (e.G., admiral, medtronic, minneapolis, minnesota).The 68 pta (percutaneous transluminal balloon angioplasty) procedures were supported by a median balloon size of 10 x 20 mm with a median peak pressure of 10 atm.In 9 cases, drug-eluting balloons were used, and in 2 cases, cutting balloons were used.The distribution was 54 (79%) as first pta, 10 (15%) as second pta, and 2 (3%) for each third and fourth pta.The total complication rate for pta was 10% versus 13% for stenting.Major events in the pta group were 2 wire-induced pv perforations with tamponade treated by pericardiocentesis and 2 balloon-induced pv ruptures with tamponade treated by emergency stenting and pericardiocentesis in 1 case and urgent surgical repair in the other case.Restenosis occurred in 36 of 68 patients (53%) after pta versus 3 of 16 patients (19%) after stent implantation.Procedural complications included 1 case of intraprocedural hemoptysis, 1 case of intraprocedural lung edema and 1 case of balloon rupture.

Manufacturer Narrative

Additional information: the use of this device in a vein is considered off label as per the ifu since the admiral¿ xtreme is indicated for percutaneous transluminal angioplasty (pta) in patients with obstructive disease of peripheral arteries.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: ADMIRAL XTREME
• Type of Device: CATHETER, ANGIOPLASTY, PERIPHERAL, TRANSLUMINAL
• Manufacturer (Section D): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; avenida paseo del cucapah #105; parque industrial el lago; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 8137322
• MDR Text Key: 129458060
• Report Number: 9612164-2018-03493
• Device Sequence Number: 1
• Product Code: LIT
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K173515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• 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: 02/21/2019
• 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: 62 YR