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

Model Number 1103

Device Problems Obstruction of Flow (2423); Deformation Due to Compressive Stress (2889); Pumping Problem (3016)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/05/2022

Event Type  Injury  

Manufacturer Narrative

Additional products: brand name: heartware ventricular assist system ¿outflow graft, model #: 1125, catalog #: 1125, expiration date: 31-jul-2023, serial or lot#: (b)(4), udi #: (b)(4).Device available for evaluation: no, mfg date: 01-jul-2018, labled for single use: yes.(b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that ventricular assist device (vad) exhibited low flows and power below normal due to suspected inflow or outflow obstruction.It was decided that the patient should undergo a pump exchange and was taken to the operating room, during the operation it was noted that the outflow graft was wrapped in the gortex and compressed, once compression was released flow and power returned to normal and pump was not exchanged.The vad remains in use.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

### a supplemental report is being submitted for device evaluation and investigation completion.Product event summary: the pump ((b)(6)) and the associated outflow graft (lot no.1533042) were not returned for evaluation.The reported low flow and low power event was confirmed through review of the controller log files revealed a steady decrease in power consumption and estimated flows beginning on (b)(6) 2022 to the parameters below normal operating range and 90 low flow alarms have been logged since (b)(6) 2022.The reported pump external compression and outflow graft compression events could not be confirmed due to insufficient evidence.Information provided by the site indicated that ventricular assist device (vad) exhibited low flows and power below normal due to suspected inflow or outflow obstruction.Of note, it was reported by the site that it was decided that the patient should undergo a pump exchange and was taken to the operating room, during the operation it was noted that the outflow graft was wrapped in the gortex and compressed, once compression was released flow and power returned to normal and pump was not exchan ged.Based on the available information, the device may have caused or contributed to the reported event.Based on the available information, the most likely root cause of the reported low flow and low power event can be attributed, but not limited, to constriction at the outflow graft due to external compression from the additional surrounding graft placed by the surgeon at implant.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: d4: lot#: 1533042 d10: no h3: yes h6: fda method code(s): b17 h6: fda results code(s): c20 h6: fda conclusion code(s): d12 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
• 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: 13569092
• MDR Text Key: 288097182
• Report Number: 3007042319-2022-02608
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707003261
• UDI-Public: 00888707003261
• 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: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/31/2020
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2018
• 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): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male