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

Model Number 12115

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

Patient Problem Pseudoaneurysm (2605)

Event Date 09/11/2017

Event Type  Injury  

Manufacturer Narrative

Investigation for this event is ongoing and results of this will be provided in a supplemental report once completed.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information via literature regarding a procedure to treat a left ventricular (lv) pseudoaneurysm following a surgical procedure in which an lv vent was inserted.The patient underwent a pericardiectomy, tricuspid valve ring repair, and bypass grafting of the right coronary artery.During cardiopulmonary bypass, a 15-french dlp vent cannula was advanced into the lv via the right superior pulmonary vein.The patient was discharged on day 28 after a protracted hospital course complicated with right ventricular failure requiring a central right ventricular assist device.A follow-up echo showed a multi-lobulated lv pseudoaneurysm.Under moderate sedation, a 6-french 100-cm pigtail catheter was advanced into the lv via a right common femoral artery access.A pre-curved 0.035¿ extra-stiff wire was then used to exchange the pigtail with a 7fr-90 cm sheath which was kept in the mid ventricle.Through the shuttle sheath, the pseudoaneurysm was accessed with a telescoping 7fr guiding catheter, 5fr multipurpose diagnostic catheter, and an angled stiff glide wire.A 12-mm vascular plug was then advanced via the 7fr guide and deployed in the defect.Adequate sealing and stability were confirmed with contrast injections via the shuttle sheath, before the plug was released.A repeat cct at 1 month showed a stable device and obliteration of the pseudoaneurysm.No device malfunctions were reported.All data was collected from a single centre.No additional adverse patient effects or product performance issues were reported.

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.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: LEFT HEART VENT
• Type of Device: SUCKER, CARDIOTOMY RETURN, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• MDR Report Key: 10470313
• MDR Text Key: 205466585
• Report Number: 2184009-2020-00045
• Device Sequence Number: 1
• Product Code: DTS
• Combination Product (y/n): N
• PMA/PMN Number: K834039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 12115
• Device Catalogue Number: 12115
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR