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

Model Number 1103

Device Problems Contamination (1120); Material Too Rigid or Stiff (1544); Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/12/2023

Event Type  malfunction  

Event Description

It was reported that the patient's driveline cover was assessed and incidentally found that it was hardened and stuck to the driveline (dl).Service was performed removing the dl cover with no issues, dust and chunks of debris were found inside and cleaned off the driveline.The dl and dl cover remain in use.No 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.Brand name: heartware ventricular assist system ¿driveline cover, model #: 1175, catalog #: 1175, expiration date: 31-may-2018, serial or lot#: (b)(4), device available for evaluation: no, mfg date: 31-may-2016, labeled for single use: no.Patient ime code(s): e2403 imf code(s): f26.Img code(s): g04037.Fda device code(s): a1801.Fda method code(s): b21.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.

Manufacturer Narrative

A supplemental report is being submitted for corrections to b5 and h6.Additional products: d4: lot#: 1155585 h6: fda device code(s): a040607 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.

Event Description

The driveline cover was replaced.

Manufacturer Narrative

A supplemental report is being submitted for additional information and device evaluation.Product event summary: the driveline cable associated with (b)(6) was not returned for evaluation.The driveline boot cover (lot r017259) associated with the surgical tool kit (lot 1155585) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the devices in relation to the reported event.A review of the driveline cover's inspection records confirmed that the associated device met all requirements for release.Review of the controller log files revealed no anomalies within the analyzed period.On-site inspection of the driveline cover revealed that the device was stuck on the driveline.Visual inspection of the returned device revealed that the driveline cover was received in a damaged condition; therefore, functional testing and dimensional verification could not be performed.Supplemental testing previously performed on similar samples revealed that the driveline covers analyzed exhibited increased hardness and material stiffness as compared to a control sample.Visual inspection of the returned boot cover also revealed foreign material within the device.Onsite inspection of the driveline and boot cover also revealed foreign material between the driveline cover and the outside of the driveline cable¿s connector.As a result, the reported event was confirmed.A stuck driveline cover removal was performed to mitigate the reported conditions.A possible root cause of the reported foreign material event can be attributed, but not limited, to the handling of the device.Based on historical review of similar events and the investigation conducted, a possible root cause of the reported stuck driveline cover event can be attributed, but not limited, to leaching of the plasticizer from the material and/or degradation of the material, resulting in hardening and shrinkage.Capa pr00536773 is further investigating this issue.Additional products: d4: expiration date: / lot#: r017259 udi #: d9: yes, return date: 01-feb-2023 h3: yes dev rtn to mfr? yes h4: mfg date: h6: fda method code(s): b01, b14, b15 h6: fda results code(s): c06, c07 h6: fda conclusion code(s): d1501 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: 16214897
• MDR Text Key: 308943202
• Report Number: 3007042319-2023-00172
• Device Sequence Number: 1
• Product Code: DSQ
• UDI-Device Identifier: 00888707000017
• UDI-Public: 00888707000017
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2018
• Device Model Number: 1103
• Device Catalogue Number: 1103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• 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 Age: 75 YR
• Patient Sex: Male