MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER EVIDENT; SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES

Model Number	VTGEN
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Cardiomyopathy (1764)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Title new microwave ablation system for unresectable liver tumors that forms large, spherical ablation zones source journal of gastroenterology and hepatology, volume 33, 2018 (2007¿2014) date of publication: 15 may 2018.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to literature source of study performed march 2017 and december 2017, there were no deaths of any of patients who underwent mwa.However, one patient experienced an adrenal gland-induced takotsubo (stress) cardiomyopathy immediately after mwa.Additionally, one subdiaphragmatic hcc nodule ablation was complicated by a pleural effusion, and ablation of a hcc nodule near the bile duct was complicated by a biloma, diagnosed by ct after the ablation.These complications were resolved by conservative medical treatment.Regarding the takotsubo cardiomyopathy, authors state that ¿it was associated with microwave ablation was noted in (b)(6) year-old patient with hcc located in liver lobe s7 received mwa ablation.The diameter of the tumor was 45.1 mm in the long-axis diameter41.1 mm in the short-axis diameter, and 40.2 mm in the vertical axis diameter.The mwa antenna was inserted percutaneously by an expert in local hcc treatment.The patient had severe hypertension (systolic blood pressure/diastolic blood pressure, 264/133 mmhg) during the mwa (approximately 9 min ablated by 100 w) following ventricular tachycardia despite discontinuation of the ablation.Cardiac catheterization was performed immediately, and the issue was diagnosed as takotsubo cardiomyopathy.The patient recovered under conservative medical treatment after approximately 1 week following the mwa.The post-procedure ct scan showed the residual hcc and the ablated right adrenal gland despite a nondirect puncture.The authors further note in the discussion section that the ¿takotsubo cardiomyopathy observed in one patient was probably induced by excessive catecholamines derived from the ablated adrenal gland.Therefore, the mwa active zone must be placed at least 1 cm from surrounding organs such as the adrenal gland.

• Brand Name: EVIDENT
• Common Device Name: SYSTEM, ABLATION, MICROWAVE AND ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 8332035
• Report Number: 1717344-2019-00192
• Device Sequence Number: 18848153
• Product Code: NEY
• UDI-Device Identifier: 10884524001579
• UDI-Public: 10884524001579
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K011676
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,l
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/12/2019

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: VTGEN
• Device Catalogue Number: VTGEN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2019
• Initial Report FDA Received Date: 02/12/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR