MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH ADVANCE STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 3FC12

Device Problem Insufficient Information (3190)

Patient Problems Neurological Deficit/Dysfunction (1982); Transient Ischemic Attack (2109); Pericardial Effusion (3271)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Liu j, kaufmann j, kriatselis c, fleck e, gerds-li j.Outcome of cryoballoon ablation for atrial fibrillation: medium-term follow-up from a single center.Herz.2015;40(2):125-129.Objective: we analyzed the medium-term follow-up of cryoballoon ablation (cba) for atrial fibrillation (af) and the clinical risk factors predicting outcome.Methods: af patients treated for the first time with cba in a 4.5-year period were studied retrospectively.Pulmonary vein isolation (pvi) was achieved via a single cryoballoon with diameter of 28 mm.Left atrial diameter (lad) was measured by transthoracic echocardiography.Failure of cryoablation treatment was defined as detection of an episode of af, atrial flutter, or atrial tachycardia lasting more than 30 s during the 3-month follow-up.Results: a total of 212 patients were enrolled and in 87.7 % patients pvi was achieved by cba.The complication rate was 2.83 %.The mean follow-up was 28 ± 15 months; in 166 patients follow-up was complete.The rate of successful treatment for primary cba was 45.8 %.The percentage of patients who experienced atrial arrhythmia recurrence in the first 12 months was 84.44 %.Patients in whom treatment failed had a larger lad (47 ± 6 mm vs.43 ± 5 mm, p <(><<)> 0.0001).The kaplan-meier curve showed that the patients with lad <(><<)> 45 mm had a higher success rate than patients with lad ? 45 mm [57.9 % (44/76) vs.35.6 % (32/90), log rank = 5.492, p = 0.019].The lad [odds ratio, or = - 0.1053(0.303, 12.2040), p = 0.0005] was shown in logistic regression analysis to be independently predictive of cba treatment failure.Conclusion: the cba procedure for af patients is safe and effective.Most atrial arrhythmia recurrences occurred during the first 12 months after cba.The lad can independently predict failure of cba treatment.The literature publication reports the following complications: three patients with phrenic nerve palsy (pnp) - two resolved when cryoablation was stopped, one resolved seven months after procedure; one patient with pericardial effusion which resolved spontaneously; and two patients with transient ischemic attack (tia).

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: liu j, kaufmann j, kriatselis c, fleck e, gerds-li j.Outcome of cryoballoon ablation for atrial fibrillation: medium-term follow-up from a single center.Herz.2015;40(2):125-129.(b)(4).

Manufacturer Narrative

Product event summary #risk analysis: risk analysis: rar-006-01.Category 2: biological / clinical hazards ¿ 2.10.Cardiac perforation, pericardial effusion, tamponade (vascular damage), 2.10.1.Excessive catheter maneuvering (in general, due to loss of catheter m maneuverability).Severity 4 / 2.10.Cardiac perforation, pericardial effusion, tamponade (vascular damage),2.10.3.Excessive guidewire maneuvering or mapping catheter maneuvering.Severity 4 / 2.10.Cardiac perforation,pericardial effusion, tamponade (vascular dam age),2.10.5.Pulling while frozen.Severity 4./ 2.16.Collateral damage,2.16.2.Ablation to the phrenic nerve / vagal nerve.Severity 4 / 2.19 delayed procedure.2.19.1.Forced catheter exchange due to system notice or other system abnormality.Severity 2.Fmea0021, 11.Catheter positioning - enable mapping.Unable to deploy loop array and/or manipulate catheter.Damage to heart tissue / vasculature.Severity 7 pha: 10031026doc.5.Transseptal puncture ¿ procedure: arterial embolic event - minor (clinical).Severity ranking 7 / 7.Catheter (eg.Cryoballoon) insertion and deployment: maneuver sheath to the targeted tissue.Perforation of myocardial tissue - moderate (clinical).Severity ranking 8 / 7.Catheter (eg.Cryoballoon) insertion and deployment: maneuver sheath to the targeted tissue.Failure to treat severity ranking 6 investigation conducted: n/a result of investigation: neither bin files nor product has been returned for analysis.These were clinical adverse events encountered during procedure.A journal article was written regarding these events.Final resolution: no indication of product malfunction and no product to be returned.Corrective action gcapa #(b)(4)was issued to investigate the risk of phrenic nerve injury after cryoablation with arctic front and arctic front advance catheters.Corrective action gcapa # (b)(4) was issued to investigate the risk of cardiac perforation, pericardial effusion and tamponade associated with cryoablation for atrial fibrillation.This report will be recorded and trended.(b)(4).

Event Description

Liu j, kaufmann j, kriatselis c, fleck e, gerds-li j.Outcome of cryoballoon ablation for atrial fibrillation: medium-term follow-up from a single center.Herz.2015;40(2):125-129.Objective: we analyzed the medium-term follow-up of cryoballoon ablation (cba) for atrial fibrillation (af) and the clinical risk factors predicting outcome.Methods: af patients treated for the first time with cba in a 4.5-year period were studied retrospectively.Pulmonary vein isolation (pvi) was achieved via a single cryoballoon with diameter of 28 mm.Left atrial diameter (lad) was measured by transthoracic echocardiography.Failure of cryoablation treatment was defined as detection of an episode of af, atrial flutter, or atrial tachycardia lasting more than 30 s during the 3-month follow-up.Results: a total of 212 patients were enrolled and in 87.7 % patients pvi was achieved by cba.The complication rate was 2.83 %.The mean follow-up was 28 ᠱ5 months; in 166 patients follow-up was complete.The rate of successful treatment for primary cba was 45.8 %.The percentage of patients who experienced atrial arrhythmia recurrence in the first 12 months was 84.44 %.Patients in whom treatment failed had a larger lad (47 ᠶ mm vs.43 ᠵ mm, p <(><<)> 0.0001).The kaplan-meier curve showed that the patients with lad <(><<)> 45 mm had a higher success rate than patients with lad ? 45 mm [57.9 % (44/76) vs.35.6 % (32/90), log rank = 5.492, p = 0.019].The lad [odds ratio, or = - 0.1053(0.303, 12.2040), p = 0.0005] was shown in logistic regression analysis to be independently predictive of cba treatment failure.Conclusion: the cba procedure for af patients is safe and effective.Most atrial arrhythmia recurrences occurred during the first 12 months after cba.The lad can independently predict failure of cba treatment.The literature publication reports the following complications: three patients with phrenic nerve palsy (pnp) - two resolved when cryoablation was stopped, one resolved seven months after procedure; one patient with pericardial effusion which resolved spontaneously; and two patients with transient ischemic attack (tia).

• Brand Name: FLEXCATH ADVANCE STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• 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: 4953355
• MDR Text Key: 18271744
• Report Number: 3002648230-2015-00207
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,foreign,health profe
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 3FC12
• Device Catalogue Number: 3FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2015
• Initial Date FDA Received: 07/30/2015
• 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