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

Model Number MCS1705PU

Device Problem Material Discolored (1170)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 06/12/2022

Event Type  Injury  

Event Description

It was reported that the ventricular assist device (vad) patient driveline had some blood inside and also the driveline cable showed some discoloration from the driveline dressing down to the connector.The driveline remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

A supplemental report is being submitted for investigation completion.Product event summary: the driveline cable associated with (b)(6) was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.Review of the available log files did not reveal any anomalies within the analyzed period.Visual evidence provided by the site revealed blood in the driveline cable.As a result, the reported event was confirmed.An isolation of blood servicing procedure was not performed.Additionally, visual evidence provided by the site revealed damage to the driveline strain relief.This is an additional finding not related to the reported event.The most likely root cause of the observed driveline strain relief damage may be attributed, but not limited, to factors such as normal wear over time and/or improper handling.Based on the risk documentation, a possible root cause of the blood in the driveline can be attributed, but not limited to damage via cut or nick of the pump¿s driveline outer sheath.Per the instructions for use, bleeding is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, the patient did not have a history of bleeding.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.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 - DRIVELINE
• Type of Device: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer (Section G): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 14776271
• MDR Text Key: 294614842
• Report Number: 3007042319-2022-05483
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707005364
• UDI-Public: 00888707005364
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: MCS1705PU
• Device Catalogue Number: MCS1705PU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Date Device Manufactured: 02/22/2021
• 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: 49 YR
• Patient Sex: Male