MAUDE Adverse Event Report: HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT; VENTRICULAR (ASSIST) BYPASS

Device Problems Leak/Splash (1354); Device Damaged Prior to Use (2284); Misassembly by Users (3133); Material Split, Cut or Torn (4008)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/18/2019

Event Type  Injury  

Manufacturer Narrative

This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac transplantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.This event occurred outside the u.S.All information provided is included in this report.Patient information is limited due to confidentiality concerns.A one to one correlation could not be made with unique device serial numbers.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: early postoperative rupture of heartware outflow graft: a case report.Journal of cardiac surgery, august 2019; 34(8):742-744.Doi: 10.1111/jocs.14120.If information is provided in the future, a supplemental report will be issued.

Event Description

A journal article was reviewed which contained information regarding ventricular assist devices (vads).The article discussed a case report of post-operative outflow graft rupture.One patient's post-operative course was complicated by the development of surgical site bleeding.The patient was taken back to the operating room and underwent re-sternotomy, wherein intensive mediastinal hemorrhage was discovered.Bleeding was isolated to a rupture at the junction of the outflow graft with the pump.The graft was exchanged.The article notes the rupture was a perforation of the graft caused by squeezing/crushing of the graft material between the clamp and connection point to the pump outlet, possibly occurring during assembly in surgery.The status/location of the vad is unknown.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: outflow graft with unknown lot number was not returned for evaluation.Visual evidence provided revealed a tear in the outflow graft, thus confirming the reported event.An internal investigation examined tears in the outflow graft.Based on this investigation, the most likely root cause of tears or cuts in the outflow graft has been attributed to design issues.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.

Manufacturer Narrative

Supplemental mdr report is being submitted to include the associated fda z-number issued for the reported issue captured in this report.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: HEARTWARE VENTRICULAR ASSIST SYSTEM - OUTFLOW GRAFT
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 9154012
• MDR Text Key: 161714138
• Report Number: 3007042319-2019-12028
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 06/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: Z-2058-2020
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 54 YR