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

Model Number	1125
Medical Device Problem Codes	Obstruction of Flow (2423); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: heartware ventricular assist system ¿ outflow graft, model#: 1125 / catalog#: 1125 / expiration date: unk / lot#: unk, udi #: (b)(4), device available for evaluation : no; mfg date: unk, labeled for single use: no.(b)(4).Additional information has been requested regarding the out flow graft lot# & disposition, the vad exchange details, and the intervention of the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.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.
Event or Problem Description
It was reported that the patient experienced stenosis of the outflow graft.The ventricular assist device (vad) was exchanged for an unknown reason and the status of the outflow graft is unknown at this time.No further patient complications have been reported as a result of this event.
Event or Problem Description
It was further reported that there was no intervention for the outflow graft obstruction.The outflow graft remains in use and no patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
A supplemental report is being submitted for corrections as the ventricular assist device (vad) has been determined not to be associated with the reported event and the outflow graft is the only product to be captured in this event.Information pertaining to the vad which was submitted in the initial report for this event, is a duplicate and is captured in regulatory report #3007042319-2022-06730.Corrections were made to: b1.Adv evnt/prod prob: from: adverse event & product problem, to: product problem b3.Date of event: from 2019-01-01 to: 2022-05-01 b5.Desc evt problem: from: it was reported that the patient experienced stenosis of the outflow graft.The ventricular assist device (vad) was exchanged for an unknown reason and the status of the outflow graft is unknown at this time.No further patient complications have been reported as a result of this event.,to: it was further reported that there was no intervention for the outflow graft obstruction.The outflow graft remains in use and no patient complications have been reported as a result of this event.D1.Brand name: from: heartware ventricular assist system ¿ pump to: heartware ventricular assist system - outflow graft d4.Model #, catalog # : from: 1104, to: 1125 expiration date: from: 2019-09-30, to: blank serial #: from: (b)(6), to: blank lot #: from: blank, to: 16143533-981 unique identifier #: from: (b)(6), to: (b)(6), d6a.Implanted date: from blank, to: (b)(6) 2017, d6b.Explanted date: from (b)(6) 2019, to: blank g3.Date mfr rec: from: 2022-07-04, to: 2022-07-19 h6: patient codes (ime/annex e): from e2401, to: e2403 h6: imf code(s): from: f1203, f08, f19, to: f26 investigation of this event is pending and a supplemental report will be sent upon its completion.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.
Additional Manufacturer Narrative
A supplemental report is being submitted for investigation completion.Product event summary: the outflow graft (lot 16143533-981) was not returned for evaluation.Log file analysis was not performed since log files were not available for analysis.The reported stenosis event could not be confirmed due to insufficient information.Based on the available information, the device may have caused or contributed to the reported 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 - OUTFLOW GRAFT
• Common Device Name: 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: 15008160
• Report Number: 3007042319-2022-06542
• Device Sequence Number: 6856245
• Product Code: DSQ
• UDI-Device Identifier: 00888707000222
• UDI-Public: 00888707000222
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2019
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 09/30/2019
• Device Model Number: 1125
• Device Catalogue Number: 1125
• Device Lot Number: 16143533-981
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2022
• Supplement Date Received by Manufacturer: 07/19/2022; 09/09/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 07/28/2022; 09/13/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 23 YR
• Patient Sex: Male