MAUDE Adverse Event Report: MEDTRONIC ADVANCED ENERGY, LLC UNKNOWN MAE GENERATOR; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number MAE UNK GEN

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

Patient Problems Fistula (1862); Pleural Effusion (2010); Pneumonia (2011); Reaction (2414); Ascites (2596); Blood Loss (2597)

Event Date 04/11/2019

Event Type  Injury  

Manufacturer Narrative

Product event: (b)(4).Patient information unable to be obtained despite a good faith effort made to obtain the information from the customer.If information is provided in the future, a supplemental report will be issued.

Event Description

Article title: "assessment of the effect of the aquamantys® system on local recurrence after hepatectomy for hepatocellular carcinoma through propensity score matching." objective: to assess the effect of the intraoperative application of the aquamantys ® system to treat the hepatic resection margin on local and overall recurrence of hcc.Methods: we retrospectively analyzed 101 patients admitted from november 2016 to june 2018 who underwent hepatectomy using the aquamantys® as hemostatic device, who were matched with 101 patients (control group) using conventional hemostatic devices through psm.Univariate and multivariate analyses of recurrence-free survival (rfs) and local recurrence-free survival (lrfs) were performed using the cox proportional hazard model.Results: there were no significant differences in baseline data and surgical procedures between the two groups.The aquamantys ® group showed less blood loss (p = 0.005) and a lower blood transfusion rate (p = 0.036), while the incidences of postoperative complications of the two groups showed no difference (p = 0.266).Os rates of the aquamantys ® group and the control group were 82.6% and 84.2%, respectively (p = 0.446), and rfs rates were 65.5% and 58.2%, respectively (p = 0.153), with no significant differences.The aquamantys ® group and the control group had two cases and 11 cases of local recurrence, respectively, with lrfs rates of 98% and 87.9%, respectively, in the follow-up period, corresponding to a significant difference (p = 0.011).Multivariate analysis showed that microvascular invasion (mvi), tumor diameter > 5 cm, and the control group were independent risk factors for lrfs.Aqm group: 101 patients, age mean 57 years, 82 male and 10 female adverse effects: 8 patients received a blood transfusion 1 patient experienced bile leakage 1 patient experienced a pleural effusion 2 patients experienced pneumonia 5 patients experienced ascites 1 patient experienced a perioperative biliary fistula without intra-abdominal hemorrhage there were no patient identifiers within the article; therefore, the patients will be reported as a whole and no other records will be created.

• Brand Name: UNKNOWN MAE GENERATOR
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer (Section G): MEDTRONIC ADVANCED ENERGY, LLC; 180 international drive; portsmouth NH 03801
• Manufacturer Contact: kaylee boisvert ; 180 international drive; portsmouth, NH 03801 ; 6038426234
• MDR Report Key: 8577666
• MDR Text Key: 143969978
• Report Number: 1226420-2019-00097
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/03/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MAE UNK GEN
• Device Catalogue Number: MAE UNK GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention