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

Model Number 1103

Device Problems Malposition of Device (2616); Connection Problem (2900); Pumping Problem (3016)

Patient Problems Thrombus (2101); Thrombosis/Thrombus (4440)

Event Date 08/08/2020

Event Type  Injury  

Manufacturer Narrative

Concomitant medical products: 5076-58 lead implanted on (b)(6) 2011, 419488 lead implanted on (b)(6) 2011, 5076-52 lead implanted on (b)(6) 2005, 694965 lead implanted on (b)(6) 2005.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.

Event Description

It was reported that the ventricular assist device (vad) exhibited a vad stop due to driveline disconnection, and intermittent high watt alarms.The driveline cover was found to be on backwards and was not corrected due to suspicion of thrombus.The vad and driveline cover were exchanged.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted device evaluation and correction.Correction h10: h10 was corrected to include the driveline cover as an additional product associated with the event.Product event summary: the ventricular assist device (vad) was returned for evaluation.The associated driveline cover was not returned for evaluation.Log file analysis was not conducted since log files covering the reported event date were not available.As a result, the reported driveline disconnect and high power events could not be confirmed.Failure analysis of the returned pump revealed that the device passed functional testing and dimensional verification but visual examination revealed scoring marks on the lower housing ceramic surface and on the inferior surface of the impeller.Considering that the returned device passed functional examination, these friction marks are indicative that an external factor such as thrombus may have forced the impeller against the rear housing with sufficient strength to overcome the rear preload of the magnetic spring/suspension system.As such, the presence of friction marks is likely a symptom of the clinical challenge the pump has experienced and is generally not evidence of a pump induced problem.Internal pathological report revealed evidence of thrombus within the device.Additionally, visual evidence provided by the site revealed that the driveline cover was placed backwards.As a result, the reported backwards placement of the driveline cover event was confirmed.Based on the available information, there is no evidence to indicate that a device malfunction caused or contributed to the reported event.The most likely root cause of the reported driveline disconnect event may be attributed to a physical disconnection of the driveline from the controller as a result of the incorrect placement of the driveline cover.Based on the investigation conducted and applicable risk documentation, the most likely root cause of the reported high power event can be attributed to external factors such as thrombus formation/ingestion.Per the instructions for use, device thrombus is a known potential complication associated with the implantation of a vad.There was no evidence that the patient had a history of thrombus events.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.Additional products: d1: heartware ventricular assist system ¿ driveline cover d4: model #: 1175/ catalog #: 1175/ expiration date: unk / lot#: unk udi #: asku d10: no h3: yes h4: mfg date: unk h5: no h6: patient ime code(s): e0514 h6: imf code(s): f1203, f08, f1903 h6: device code(s): a150202 h6: fda method code(s): b15, b17 h6: fda results code(s): c07 h6: fda conclusion code(s): d11 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 - PUMP/DRIVELINE
• Type of Device: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 10424882
• MDR Text Key: 203470294
• Report Number: 3007042319-2020-05358
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707002639
• UDI-Public: 00888707002639
• Combination Product (y/n): N
• PMA/PMN Number: P100047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 08/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Date Manufacturer Received: 11/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: DTBA1D1 ICD,; DTBA1D1 ICD,
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 72 YR