MAUDE Adverse Event Report: MEDTRONIC, INC DXTERITY; CATHETER, INTRAVASCULAR, DIAGNOSTIC

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

Patient Problem Vascular Dissection (3160)

Event Date 09/29/2021

Event Type  Injury  

Manufacturer Narrative

Title: optimized computed tomography acquisition protocol for ethanol infusion into the vein of marshall year: 2022 reference: doi: 10.1016/j.Jacep.2021.09.020 a2: average age a3: majority gender b3: date of publication medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was submitted for review titled "optimized computed tomography acquisition protocol for ethanol infusion into the vein of marshall".The vein of marshall (vom) is an embryonic remnant of the left superior vena cava that descends along the posterolateral aspect of the left atrium (la) and drains into the coronary sinus (cs), which plays an important role in the maintenance of certain atrial tachyarrhythmias.Ethanol infusion into the vom (et-vom) has been reported as an effective treatment for atrial tachyarrhythmia.The ability of computed tomography scan (ct) to visualize the vom is relatively low.To overcome this issue, this study introduces an optimized ct acquisition protocol dedicated to visualization of the vom.The aims of this study were to evaluate the feasibility of this optimized ct protocol for visualizing the vom, and to analyze the impact of integrating this imaging information on et-vom procedures.Between april 2019 and january 2021, the study prospectively included consecutive patients with drug-resistant atrial fibrillation (af) undergoing cardiac ct for preprocedural work-up before ablation.Ct was performed in 258 consecutive patients.Two different ct acquisition protocols were implemented.The first was with a conventional approach where acquisition is performed at the time of la enhancement peak (conv-ct).The second was with a modified contrast bolus injection protocol and a slightly delayed acquisition designed to optimize both la and cs enhancement (vom-ct).The conv-ct group consisted of 132 patients, whereas the vom-ct group consisted of 126 patients.The detection of the vom was assessed and compared between the 2 groups.Vom was detected in 35% in conv-ct versus 63% in vom-ct.All patients underwent ct without complications and image quality was technically adequate.In the subset of patients undergoing et-vom, a long steerable non mdt sheath was inserted into the cs, through which a medtronic 5-f dxterity left internal mammary artery angiography catheter was advanced for cs venography.All patients underwent cs venography.Once the vom was identified, an angioplasty guidewire was gently advanced into the vom, followed by an over-the-wire balloon catheter.After inflating the balloon, the guidewire was removed.A total of 10 ml of 96% ethanol was infused into the vom (3 separate 1-minute injections).To analyze whether the optimized ct protocol improved the overall et-vom procedure, the total radiation time, the procedure time, the total amount of the contrast medium, the number of contrast injections required to detect the vom, and the number of complications during et-vom were documented and compared among the groups.Et-vom was performed in 77 patients in the conv-ct group and 70 patients in the vom-ct group without complication except for cs dissection.There were 18 patients who underwent et-vom without ct images (without-ct group).Across the 3 groups, et-vom was accomplished in 71, 65, and 17 patients from the conv-ct, vom-ct, and without-ct group, respectively.It failed in 12 patients due to undetectable vom, difficulty of vom cannulation, or cs dissection.

Manufacturer Narrative

Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.

• Brand Name: DXTERITY
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15804779
• MDR Text Key: 303720452
• Report Number: 1220452-2022-00086
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K161287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/18/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 11/16/2022
• Supplement Dates Manufacturer Received: 11/16/2022
• Supplement Dates FDA Received: 11/18/2022
• 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): Other
• Patient Age: 64 YR
• Patient Sex: Male