MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF283

Device Problem Insufficient Information (3190)

Patient Problems Transient Ischemic Attack (2109); Pseudoaneurysm (2605)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Bordignon s, furnkranz a, perrotta l, et al.High rate of durable pulmonary vein isolation after second-generation cryoballoon ablation: analysis of repeat procedures.Europace.2015;17(5):725-731.Aims pulmonary vein isolation (pvi) using the first-generation cryoballoon (cb1) was characterized by a high rate of recovered pulmo nary vein (pv) conduction along with a typical conduction gap pattern in patients with recurrent atrial tachyarrhythmia (ata).Second generation (cb2) enables more uniform freezing.However, the rate of chronic pvi and pv conduction gap pattern is unknown.Methods and results all patients with ata recurrence undergoing a second procedure after cb2 or (historical) cb1 pvi (28 mm) were enrolled.In all patients, a left atrial three-dimensional electronatomic reconstruction was performed.The rates of chronic pvi and localization of pv conduction gaps were determined and compared between cb1 and cb2.Antral pv re-isolation was performed using irrigated-tip radiofrequency current energy ablation.Of 206 patients (cb2), 18 pati ents underwent the repeat procedure after 192 (75:245) days.In 6 of 18 (33%) patients, all pvs were electrically isolated whereas in the remaining 12 patients (66%) at least one pv demonstrated pv reconduction.Of 71 pvs [1 left common pv (lcpv)], 55 pvs (77%) were chronically isolated.The right superior pv (rspv) was characterized by the lowest rate of chronic pvi (rspv: 56%, lspv: 76%, ripv: 83%, lipv: 94%, lcpv: 100%).Compared with cb1, cb2 ablation resulted in a significantly higher rate of chronic pvi (cb2: 77% vs.Cb1: 32%; p <(> <<)> 0.0001) with the greatest improvement along both inferior pvs.Conclusion second-generation cryoballoon atrial fibrillation ablation is associated with a high rate of durable pvi in patients with ata recurrence.The rspv represents the pv with the greatest risk for left atrium-pulmonary vein reconnection.The literature publication reports the following complications: one patient experienced a transient ischemic attack (tia) and one patient experienced a "false aneurysm.".

Manufacturer Narrative

Medtronic cryocath was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.Referenced article: bordignon s, furnkranz a, perrotta l, et al.High rate of durable pulmonary vein isolation after second-generation cryoballoon ablation: analysis of repeat procedures.Europace.2015;17(5):725-731.(b)(4).

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 4952672
• MDR Text Key: 15838411
• Report Number: 3002648230-2015-00205
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P0100010/S01
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/07/2015
• 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): Hospitalization; Life Threatening