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

Model Number 1175

Device Problem Difficult to Remove (1528)

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

Event Date 05/04/2022

Event Type  malfunction  

Event Description

It was reported that the cover on the driveline connector had hardened and was difficult to pull back off of the connector.It was noted that there were no alarms, the driveline connector did not pull out when the cover was removed, and no damage was done to the driveline upon removal of the cover.The site cut off the driveline cover and the driveline cover was removed from service.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.Additional information has been requested regarding the missing lot number as well as the concomitant vad model and therapy date, 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.

Manufacturer Narrative

A supplemental report is being submitted for device evaluation.Product event summary: the driveline boot cover with unknown lot number was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.A review of the driveline cover's inspection documentation could not be conducted since the lot number was unknown.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.Additionally, visual inspection revealed slight discoloration around the edge of the driveline cover.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.As a result, the reported hardening of the driveline cover and difficulty removing the driveline cover were confirmed.Based on historical review of similar events and the investigation conducted, a possible root cause of the reported 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.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.

Manufacturer Narrative

A supplemental report is being submitted for inclusion of this event as being in-scope for field action 3007042319-12-06-2022-005-c.This event was submitted historically and has been deemed in-scope for the field corrective action.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 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: 14526560
• MDR Text Key: 300645443
• Report Number: 3007042319-2022-05265
• Device Sequence Number: 1
• Product Code: DSQ
• 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,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 1175
• Device Catalogue Number: 1175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/05/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 07/15/2022; 12/07/2022
• Supplement Dates FDA Received: 07/21/2022; 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 300704231912062022005C
• Patient Sequence Number: 1
• Treatment: MCS UNKNOWN VAD.
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Weight: 106 KG