MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT HEART VENT CATHETER; SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS

Model Number 12016

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

Patient Problem Pseudoaneurysm (2605)

Event Date 01/25/2019

Event Type  Injury  

Manufacturer Narrative

Citation authors:takahisa okano, katsuji fujiwara and hitoshi yaku article title: a pseudoaneurysm of the left ventricular apex in the perioperative period caused by left ventricular venting via the right superior pulmonary vein during open heart surgery.Journal:journal of japan surgical association year:2019 volume:80 issue:1.Earliest date of publish used for event date.No unique device identifier were provided; without this information, it could not be determined whether these observations have been previously reported.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a left ventricular pseudoaneurysm formation after aortic valve replacement.All data was collected from a single centre and patient.Fourteen days after the aortic valve replacement transthoracic echocardiography revealed a "to-and-fro" mosaic blood flow to the left ventricular apex with an increased flow velocity of 3.8 mm/s and a 1×8 mm pseudoaneurysm.Cardiac contrast-enhanced ct showed a ventricular mass 20 mm in diameter at the apex.The patient¿s chest was reopened, and a thumb-sized mass was found at the left ventricular apex and the epicardium was thickened.When the epicardium was incised just above the aneurysm, there was a cavity immediately below and blood spouted from the left ventricle.A 2-0 monofilament thread and a teflon felt were sandwiched to straddle the lump, avoiding the left anterior descending branch, and an "over-and-over" suture closure was performed with a 2-0 monofilament thread.The total operation time was 3 hours and 6 minutes and the extracorporeal circulation time was 35 minutes.The patient was extubated on the day of surgery and was discharged on postoperative day 20.It was inferred from the histopathological findings and electrocardiogram findings that this case was an endocardial myocardium damage and pseudoaneurysm caused by left ventricular vent catheter placement via the right superior pulmonary vein during operation.A medtronic dlp left vent catheter (the lot number was not provided) was used during the aortic valve replacement procedure.No malfunctions were reported.No additional adverse patient effects or product performance issues were reported.

Manufacturer Narrative

Updated information; h4: model 12016.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.

• Brand Name: DLP LEFT HEART VENT CATHETER
• Type of Device: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 8691949
• MDR Text Key: 147754288
• Report Number: 2184009-2019-00038
• Device Sequence Number: 1
• Product Code: DTS
• Combination Product (y/n): N
• PMA/PMN Number: K834352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 07/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12016
• Device Catalogue Number: 12016
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR