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

Model Number 1153

Device Problems Misassembled (1398); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/28/2020

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.Additional products: heartware ventricular assist system ¿ outflow graft, model #: 1125 / catalog #: 1125 / expiration date: 28-feb-2021 / lot#: 2002669671, udi #:(b)(4).Device available for evaluation: no.Mfg date: 28-feb-2019.Labeled for single use: yes.B)(4).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 there was improper use of the outflow graft strain relief.It was stated that the "old piece is adhered and will not move" and the "new portion is shorter due to the reduction in length".The two portions of the strain relief would not meet and there was a gap between them.It was noted there as an assembly error related to the outflow graft and outflow graft strain relief.The outflow graft and outflow graft strain relief were implanted and remain in use.No patient complications have been reported as a result of this event.

Event Description

It was further reported that the original outflow graft which was anastamosed on to the ascending aorta would not move.The patient had adhesions due to being on device support for several years.The surgeon performed an end-to-end anastomosis in which the original outflow graft was anastomosed to the outflow graft arising off the new pump.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

A supplemental report is being submitted for additional inforamtion.Newly received information was updated in b5 event description and fdp code was updated for the system reported outflow graft in h10.Additional products: d4: lot#: 2002669671 h6: patient code(s): c64343 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.

Manufacturer Narrative

A supplemental correction report is being submitted to include the information regarding system reported product.H10 updated.Additional products: outflow graft h6: fda method code(s): b17 h6: fda results code(s): 3221 h6: fda conclusion code(s): 67.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

A supplemental report is being submitted for investigation completion.Product event summary: the outflow graft and strain relief were not returned for evaluation.The reported event could not be confirmed due to insufficient evidence.Of note, it was reported that, during a pump exchange, the original outflow graft was unable to be removed due to tissue adhesion.Therefore, the new outflow graft had to be anastomosed to the original outflow graft, resulting in a gap between the two portions of the strain relief.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the available information, a possible root cause of the reported event can be attributed to surgical technique during the pump exchange, as described in the reported event details.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.

Manufacturer Narrative

A supplemental report is being submitted for a correction.Corrected fields: h1 type of report: updated to serious injury b1 adv event/product problem updated outcome attributed to adverse event selected in b2 imf code was updated this regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.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 Description

It was reported that there was improper use of the outflow graft strain relief.It was stated that the "old piece is adhered and will not move" and the "new portion is shorter due to the reduction in length".The two portions of the strain relief would not meet and there was a gap between them.It was noted there as an assembly error related to the outflow graft and outflow graft strain relief.It was further reported that the original outflow graft which was anastamosed on to the ascending aorta would not move.The patient had adhesions due to being on device support for several years.The surgeon performed an end-to-end anastomosis in which the original outflow graft was anastomosed to the outflow graft arising off the new pump.No further patient complications have been reported as a result of this event.The outflow graft and outflow graft strain relief were implanted and remain in use.No further patient complications have been reported as a result of this event.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP ACCESSORY
• 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: 10371288
• MDR Text Key: 242198934
• Report Number: 3007042319-2020-05230
• Device Sequence Number: 1
• Product Code: DSQ
• Combination Product (y/n): N
• Reporter Country Code: SF
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2021
• Device Model Number: 1153
• Device Catalogue Number: 1153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2021
• Date Device Manufactured: 06/30/2019
• 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
• Treatment: 1104 VAD
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 61 KG