MAUDE Adverse Event Report: MEDTRONIC, INC. CRYOFLEX SURGICAL ABLATION PROBE; SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE

Model Number 60SF2

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

Patient Problem Vascular Dissection (3160)

Event Date 09/01/2012

Event Type  Death  

Manufacturer Narrative

Date of death: the exact date of death was not reported in the article (the patient developed multiorgan failure and died on postoperative day 5).Literature article: aortic dissection type a after right atrial cryoablation during port access mitral valve surgery doi:10.1097/imi.0b013e3182744646.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a case where a (b)(6)-year-old woman underwent minimal invasive mitral and tricuspid valve repair and a concomitant cryomaze procedure.All data was collected from a single center.A medtronic cryoflex probe was used to perform the concomitant cryomaze procedure (serial or model numbers not provided).During the minimally invasive procedure the cryoflex probe was used to successfully carry out left atrial cryomaze.Each lesion was created for 2 minutes,with a target temperature of -150 c.Thereafter, the mitral valve was reconstructed with a 28-mm rigid anuloplasty ring.Subsequently, a right-sided cryomaze was performed, with lines elongating the atrial incision into the superior caval vein, then from the lateral wall of the right atrium toward the tricuspid valve annulus, and then a line from the annulus of the anterior tricuspid leaflet toward then right atrial appendage.While performing this last line a fall in blood pressure was noted, that was accompanied by a drop in electrical cerebral activity, and a rise in central venous pressure.After administration of neosynephrine, hemodynamics normalized again.In the meantime,the aortic clamp was released to perform the tricuspid valve reconstruction on the beating heart.At the same time, blood pressure, monitored in the right radial artery, disappeared, whereas it remained normal in the left radial artery.An investigation was conduced by transesophageal echocardiography and this revealed an intimal flap in the ascending aorta indicative of acute aortic dissection.Concomitantly, a bleeding from the aortic annulus was detected, the exact localization could not be defined through the minimal invasive incision, so an emergency sternotomy was performed, and the patient cooled down to 18 c.After reaching 18 c body temperature, deep hypothermic circulatory arrest was established with retrograde cerebral perfusion and the aorta was opened.The aortic wall was free of atherosclerosis, and no entry was detected in the ascending aorta and aortic arch.The ascending aorta was replaced with a 28-mm prosthesis.It was noted that the dissection also involved the right coronary sinus and the right coronary ostium, with complete detachment of the right coronary artery (rca) 1 cm distal of the origin of the artery which was also the source of the bleeding.A venous aortocoronary bypass grafting to the proximal rca was subsequently performed, and the right ostium was oversewn.The patient could not be weaned from cardio pulmonary bypass (cpb) because of respiratory compromise and a massive vascular leak caused by the long pump run (extra corporeal circulation, 545 minutes; aortic cross-clamp time, 212 minutes).Therefore, a central extracorporeal membrane oxygenation (ecmo) device was installed, and the patient was switched from cpb to the ecmo.The patient developed multiorgan failure and died on postoperative day 5.At postmortem, a dissection caused by cannulation of the right femoral artery could be ruled out because the dissection ended at the left iliac artery.Based on the available information the dissection may have been associated with the medtronic product.Based on the available information the death was not attributed to the medtronic product.No device malfunctions were mentioned in the article.

• Brand Name: CRYOFLEX SURGICAL ABLATION PROBE
• Type of Device: SURGICAL DEVICE, FOR ABLATION OF CARDIAC TISSUE
• Manufacturer (Section D): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer (Section G): MEDTRONIC, INC.; 3800 annapolis lane; minneapolis MN 55447
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 10275111
• MDR Text Key: 198841964
• Report Number: 3008592544-2020-00038
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K123733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 60SF2
• Device Catalogue Number: 60SF2
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/20/2020
• 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; Required Intervention
• Patient Age: 63 YR